Register entryShortage reported
- Registered sites
- 5
- Active NDC listings
- 237
- Live patents
- 0
- Shortage listings
- 13
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
Analytical testing5Active ingredient (API) manufacture3distribute1Finished drug manufacture2Packaging1Relabelling1Repackaging1
Sites
Registered establishments
5| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| SpecGx LLC | 100 Louis Latzer Dr., Greenville, Illinois (IL) 62246, United States (USA) | Analytical testing, Active ingredient (API) manufacture | 1419579798275046 |
| SpecGx LLC | 172 Railroad Avenue P.O. Box P, Hobart, New York (NY) 13788, United States (USA) | Analytical testing, distribute, Finished drug manufacture, Packaging, Relabelling, Repackaging | 1317295957414238 |
| SpecGx LLC | 8801 Capital Blvd., Raleigh, North Carolina (NC) 27616, United States (USA) | Analytical testing, Active ingredient (API) manufacture | 1021320097722284 |
| SpecGx LLC | 3600 N. 2nd Street, St. Louis, Missouri (MO) 63147, United States (USA) | Analytical testing, Active ingredient (API) manufacture | 1940521163205300 |
| SpecGx LLC | 381 & 385 Marshall Ave, Webster Groves, Missouri (MO) 63119, United States (USA) | Analytical testing, Finished drug manufacture | 3005275960828788054 |
Alert
Drug shortage listings
13| Drug | Presentation | Status | Availability | Posted / updated |
|---|---|---|---|---|
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletPsychiatry | Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 3.75 mg; 3.75 mg; 3.75 mg; 3.75 mg (NDC 0406-8885-01) | Current | Available | 12 Oct 202220 Aug 2026 |
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletPsychiatry | Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 2.5 mg; 2.5 mg; 2.5 mg; 2.5 mg (NDC 0406-8892-01) | Current | Limited Availability | 12 Oct 202220 Aug 2026 |
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletPsychiatry | Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 1.25 mg; 1.25 mg; 1.25 mg; 1.25 mg (NDC 0406-8891-01) | Current | Limited Availability | 12 Oct 202220 Aug 2026 |
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletPsychiatry | Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 7.5 mg; 7.5 mg; 7.5 mg; 7.5 mg (NDC 0406-8894-01) | Current | Limited Availability | 12 Oct 202220 Aug 2026 |
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletPsychiatry | Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 1.875 mg; 1.875 mg; 1.875 mg; 1.875 mg (NDC 0406-8884-01) | Current | Available | 12 Oct 202220 Aug 2026 |
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletPsychiatry | Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 5 mg; 5 mg; 5 mg; 5 mg (NDC 0406-8893-01) | Current | Available | 12 Oct 202220 Aug 2026 |
| Lisdexamfetamine Dimesylate CapsulePsychiatry | Lisdexamfetamine Dimesylate, Capsule, 30 mg (NDC 0406-5113-01) | Current | Available | 14 Jul 202320 Aug 2026 |
| Lisdexamfetamine Dimesylate CapsulePsychiatry | Lisdexamfetamine Dimesylate, Capsule, 40 mg (NDC 0406-5114-01) | Current | Available | 14 Jul 202320 Aug 2026 |
| Lisdexamfetamine Dimesylate CapsulePsychiatry | Lisdexamfetamine Dimesylate, Capsule, 70 mg (NDC 0406-5117-01) | Current | Available | 14 Jul 202320 Aug 2026 |
| Lisdexamfetamine Dimesylate CapsulePsychiatry | Lisdexamfetamine Dimesylate, Capsule, 60 mg (NDC 0406-5116-01) | Current | Available | 14 Jul 202320 Aug 2026 |
| Lisdexamfetamine Dimesylate CapsulePsychiatry | Lisdexamfetamine Dimesylate, Capsule, 10 mg (NDC 0406-5111-01) | Current | Available | 14 Jul 202320 Aug 2026 |
| Lisdexamfetamine Dimesylate CapsulePsychiatry | Lisdexamfetamine Dimesylate, Capsule, 50 mg (NDC 0406-5115-01) | Current | Available | 14 Jul 202320 Aug 2026 |
| Lisdexamfetamine Dimesylate CapsulePsychiatry | Lisdexamfetamine Dimesylate, Capsule, 20 mg (NDC 0406-5112-01) | Current | Available | 14 Jul 202320 Aug 2026 |
Catalogue
Drug listings by form and route
237237 active NDC listings: 133 human prescription drug, 83 bulk ingredient, 21 drug for further processing. By marketing category: ANDA 107, BULK INGREDIENT 81, NDA 24, DRUG FOR FURTHER PROCESSING 18, EXPORT ONLY 3.
| Dosage form | NDCs |
|---|---|
| powder | 100 |
| tablet | 53 |
| capsule | 25 |
| capsule, extended release | 19 |
| tablet, extended release | 10 |
| patch, extended release | 7 |
| tablet, chewable | 6 |
| solution | 5 |
| capsule, gelatin coated | 4 |
| concentrate | 3 |
| tablet, film coated | 3 |
| liquid | 1 |
| tablet, delayed release | 1 |
| Route | NDCs |
|---|---|
| oral | 122 |
| transdermal | 7 |
| sublingual | 4 |
| Labeller name on the listing | NDCs |
|---|---|
| specgx llc | 237 |
Catalogue
Marketed products
237Showing 150 of 237.
| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | tablet, oral | 0406-0483ANDA |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | tablet, oral | 0406-0484ANDA |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | tablet, oral | 0406-0485ANDA |
| - | ACETAMINOPHEN ANHYDROUS BASIS | powder | 0406-0114DRUG FOR FURTHER PROCESSING |
| - | ACETAMINOPHEN ANHYDROUS BASIS | powder | 0406-6114DRUG FOR FURTHER PROCESSING |
| - | ACETAMINOPHEN ANHYDROUS BASIS | powder | 0406-7509DRUG FOR FURTHER PROCESSING |
| - | AMPHETAMINE ASPARTATE | powder | 0406-3993BULK INGREDIENT |
| - | AMPHETAMINE SULFATE | powder | 0406-4942BULK INGREDIENT |
| ANAFRANIL | clomipramine hydrochloride | capsule, oral | 0406-9906NDA |
| ANAFRANIL | clomipramine hydrochloride | capsule, oral | 0406-9907NDA |
| ANAFRANIL | clomipramine hydrochloride | capsule, oral | 0406-9908NDA |
| - | Acetaminophen Anhydrous Basis | powder | 0406-0090DRUG FOR FURTHER PROCESSING |
| - | Acetaminophen Anhydrous Basis | powder | 0406-0093DRUG FOR FURTHER PROCESSING |
| - | Acetaminophen Anhydrous Basis | powder | 0406-0161DRUG FOR FURTHER PROCESSING |
| - | Acetaminophen Anhydrous Basis | powder | 0406-0244DRUG FOR FURTHER PROCESSING |
| - | Acetaminophen Anhydrous Basis | powder | 0406-0960DRUG FOR FURTHER PROCESSING |
| - | Acetaminophen Anhydrous Basis / Paracetamol Ph Eur | powder | 0406-3930DRUG FOR FURTHER PROCESSING |
| - | Acetaminophen Anhydrous Basis And Chlorpheniramine Maleate | powder | 0406-0117DRUG FOR FURTHER PROCESSING |
| Amitiza | lubiprostone | capsule, gelatin coated, oral | 23635-508NDA |
| Amitiza | lubiprostone | capsule, gelatin coated, oral | 23635-524NDA |
| Amphetamine Sulfate | Amphetamine Sulfate | tablet, oral | 0406-1219ANDA |
| Amphetamine Sulfate | Amphetamine Sulfate | tablet, oral | 0406-1220ANDA |
| - | BUPRENORPHINE BASE | powder | 0406-3205BULK INGREDIENT |
| - | BUPRENORPHINE HYDROCHLORIDE | powder | 0406-2910BULK INGREDIENT |
| - | BUPRENORPHINE HYDROCHLORIDE | powder | 0406-2933BULK INGREDIENT |
| - | BUPRENORPHINE HYDROCHLORIDE | powder | 0406-3210BULK INGREDIENT |
| Buprenorphine HCl | Buprenorphine HCl | tablet, sublingual | 0406-7012ANDA |
| Buprenorphine HCl | Buprenorphine HCl | tablet, sublingual | 0406-7018ANDA |
| - | Buprenorphine Hydrochloride | powder | 0406-3206BULK INGREDIENT |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate | Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate | tablet, sublingual | 0406-8005ANDA |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate | Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate | tablet, sublingual | 0406-8020ANDA |
| CLOMIPRAMINE HYDROCHLORIDE | clomipramine hydrochloride | capsule, oral | 0406-8806NDA |
| CLOMIPRAMINE HYDROCHLORIDE | clomipramine hydrochloride | capsule, oral | 0406-8807NDA |
| CLOMIPRAMINE HYDROCHLORIDE | clomipramine hydrochloride | capsule, oral | 0406-8808NDA |
| - | CODEINE PHOSPHATE | powder | 0406-1548BULK INGREDIENT |
| - | CODEINE SULFATE | powder | 0406-1580BULK INGREDIENT |
| - | Cocaine Hydrochloride | powder | 0406-1520BULK INGREDIENT |
| - | Codeine Phosphate | powder | 0406-1550BULK INGREDIENT |
| - | Codeine Phosphate | powder | 0406-1561BULK INGREDIENT |
| - | DEXTROAMPHETAMINE SACCHARATE | powder | 0406-2901BULK INGREDIENT |
| DEXTROAMPHETAMINE SULFATE | dextroamphetamine sulfate | tablet, oral | 0406-8958ANDA |
| DEXTROAMPHETAMINE SULFATE | dextroamphetamine sulfate | tablet, oral | 0406-8959ANDA |
| - | Dexmethylphenidate Hydrochloride | powder | 0406-1039BULK INGREDIENT |
| - | Dextroamphetamine Base | liquid | 0406-8875BULK INGREDIENT |
| - | Dextroamphetamine Saccharate Fine NP | powder | 0406-9440BULK INGREDIENT |
| - | Dextroamphetamine Saccharate NP | powder | 0406-9401BULK INGREDIENT |
| Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate | Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate | tablet, oral | 0406-8884ANDA |
| Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate | Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate | tablet, oral | 0406-8885ANDA |
| Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate | dextroamphetamine saccharate and amphetamine aspartate and dextroamphetamine sulfate and amphetamine sulfate | tablet, oral | 0406-8891ANDA |
| Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate | Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate | tablet, oral | 0406-8892ANDA |
| Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate | Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate | tablet, oral | 0406-8893ANDA |
| Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate | Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate | tablet, oral | 0406-8894ANDA |
| Dextroamphetamine Sulfate Extended-Release | dextroamphetamine sulfate | capsule, extended release, oral | 0406-8960ANDA |
| Dextroamphetamine Sulfate Extended-Release | dextroamphetamine sulfate | capsule, extended release, oral | 0406-8961ANDA |
| Dextroamphetamine Sulfate Extended-Release | dextroamphetamine sulfate | capsule, extended release, oral | 0406-8962ANDA |
| - | Dextroamphetamine Sulfate Fine NP | powder | 0406-9451BULK INGREDIENT |
| - | Dextroamphetamine Sulfate NP | powder | 0406-9450BULK INGREDIENT |
| - | Dextromethadone Hydrochloride | powder | 0406-8514BULK INGREDIENT |
| - | Dextromethadone Hydrochloride | powder | 0406-8534BULK INGREDIENT |
| - | Diphenoxylate Hydrochloride | powder | 0406-1592BULK INGREDIENT |
| Diphenoxylate Hydrochloride and Atropine Sulfate | diphenoxylate hydrochloride and atropine sulfate | tablet, oral | 0406-1236ANDA |
| - | FENTANYL ALKALOID | powder | 0406-0129BULK INGREDIENT |
| - | FENTANYL CITRATE | powder | 0406-1205BULK INGREDIENT |
| - | FENTANYL CITRATE | powder | 0406-1344BULK INGREDIENT |
| FENTANYL TRANSDERMAL | fentanyl transdermal | patch, extended release, transdermal | 0406-9037ANDA |
| FENTANYL TRANSDERMAL | fentanyl transdermal | patch, extended release, transdermal | 0406-9062ANDA |
| FENTANYL TRANSDERMAL | fentanyl transdermal | patch, extended release, transdermal | 0406-9100ANDA |
| FENTANYL TRANSDERMAL | fentanyl transdermal | patch, extended release, transdermal | 0406-9112ANDA |
| FENTANYL TRANSDERMAL | fentanyl transdermal | patch, extended release, transdermal | 0406-9125ANDA |
| FENTANYL TRANSDERMAL | fentanyl transdermal | patch, extended release, transdermal | 0406-9150ANDA |
| FENTANYL TRANSDERMAL | fentanyl transdermal | patch, extended release, transdermal | 0406-9175ANDA |
| - | Fentanyl Alkaloid | powder | 0406-5527BULK INGREDIENT |
| - | Fentanyl Citrate | powder | 0406-1130BULK INGREDIENT |
| - | Fentanyl Citrate | powder | 0406-1333BULK INGREDIENT |
| - | HYDROCODONE BITARTRATE | powder | 0406-1559BULK INGREDIENT |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | tablet, oral | 0406-0123ANDA |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | tablet, oral | 0406-0124ANDA |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | tablet, oral | 0406-0125ANDA |
| - | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | tablet | 0406-1123EXPORT ONLY |
| - | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | tablet | 0406-1124EXPORT ONLY |
| - | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | tablet | 0406-1125EXPORT ONLY |
| - | HYDROMORPHONE HYDROCHLORIDE | powder | 0406-3222BULK INGREDIENT |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | tablet, oral | 0406-0376ANDA |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | tablet, oral | 0406-0377ANDA |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | tablet, oral | 0406-0378ANDA |
| Hydromorphone Hydrochloride | hydromorphone hydrochloride | tablet, oral | 0406-3243ANDA |
| Hydromorphone Hydrochloride | hydromorphone hydrochloride | tablet, oral | 0406-3244ANDA |
| Hydromorphone Hydrochloride | hydromorphone hydrochloride | tablet, oral | 0406-3249ANDA |
| - | IBUPROFEN | powder | 0406-3823DRUG FOR FURTHER PROCESSING |
| - | Ibuprofen | powder | 0406-3825DRUG FOR FURTHER PROCESSING |
| - | LEVORPHANOL TARTRATE | powder | 0406-0545BULK INGREDIENT |
| Levorphanol Tartrate | Levorphanol Tartrate | tablet, oral | 0406-2224ANDA |
| - | Lisdexamfetamine Dimesylate | powder | 0406-0248BULK INGREDIENT |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine Dimesylate | capsule, oral | 0406-5111ANDA |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine Dimesylate | capsule, oral | 0406-5112ANDA |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine Dimesylate | capsule, oral | 0406-5113ANDA |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine Dimesylate | capsule, oral | 0406-5114ANDA |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine Dimesylate | capsule, oral | 0406-5115ANDA |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine Dimesylate | capsule, oral | 0406-5116ANDA |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine Dimesylate | capsule, oral | 0406-5117ANDA |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine Dimesylate | tablet, chewable, oral | 0406-5124ANDA |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine Dimesylate | tablet, chewable, oral | 0406-5125ANDA |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine Dimesylate | tablet, chewable, oral | 0406-5126ANDA |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine Dimesylate | tablet, chewable, oral | 0406-5127ANDA |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine Dimesylate | tablet, chewable, oral | 0406-5128ANDA |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine Dimesylate | tablet, chewable, oral | 0406-5129ANDA |
| Lubiprostone | Lubiprostone | capsule, gelatin coated, oral | 0406-6408NDA AUTHORIZED GENERIC |
| Lubiprostone | Lubiprostone | capsule, gelatin coated, oral | 0406-6424NDA AUTHORIZED GENERIC |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | tablet, oral | 0406-2540ANDA |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | tablet, oral | 0406-5755ANDA |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | tablet, oral | 0406-5771ANDA |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | solution, oral | 0406-6221ANDA |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | solution, oral | 0406-6225ANDA |
| METHADOSE | methadone hydrochloride | concentrate, oral | 0406-0527NDA |
| METHADOSE DISPERSIBLE | Methadone Hydrochloride | tablet, oral | 0406-0540ANDA |
| METHADOSE SUGAR-FREE | methadone hydrochloride | concentrate, oral | 0406-8725NDA |
| - | METHYLNALTREXONE BROMIDE | powder | 0406-1251BULK INGREDIENT |
| - | METHYLPHENIDATE | powder | 0406-7654BULK INGREDIENT |
| - | METHYLPHENIDATE HYDROCHLORIDE | powder | 0406-0570BULK INGREDIENT |
| - | METHYLPHENIDATE HYDROCHLORIDE | powder | 0406-1335BULK INGREDIENT |
| - | MORPHINE SULFATE | powder | 0406-1516BULK INGREDIENT |
| MORPHINE SULFATE | MORPHINE SULFATE | tablet, extended release, oral | 0406-8315ANDA |
| MORPHINE SULFATE | MORPHINE SULFATE | tablet, extended release, oral | 0406-8320ANDA |
| MORPHINE SULFATE | MORPHINE SULFATE | tablet, extended release, oral | 0406-8330ANDA |
| MORPHINE SULFATE | MORPHINE SULFATE | tablet, extended release, oral | 0406-8380ANDA |
| MORPHINE SULFATE | MORPHINE SULFATE | tablet, extended release, oral | 0406-8390ANDA |
| - | Methadone Hydrochloride | powder | 0406-1510BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| Methadone Hydrochloride | Methadone Hydrochloride | concentrate, oral | 0406-4123ANDA |
| - | Methadone Hydrochloride | powder | 0406-8887BULK INGREDIENT |
| - | Methadone Hydrochloride | powder | 0406-9383BULK INGREDIENT |
| Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | tablet, oral | 0406-1142ANDA |
| Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | tablet, oral | 0406-1144ANDA |
| Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | tablet, oral | 0406-1146ANDA |
| Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | tablet, extended release, oral | 0406-1445ANDA |
| Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | tablet, extended release, oral | 0406-1473ANDA |
| Methylphenidate Hydrochloride Extended-Release | Methylphenidate Hydrochloride | tablet, extended release, oral | 0406-0127ANDA |
| Methylphenidate Hydrochloride Extended-Release | Methylphenidate Hydrochloride | tablet, extended release, oral | 0406-0136ANDA |
| Methylphenidate Hydrochloride Extended-Release | Methylphenidate Hydrochloride | tablet, extended release, oral | 0406-0154ANDA |
| Methylphenidate Hydrochloride Extended-Release | methylphenidate hydrochloride | capsule, extended release, oral | 0406-1810ANDA |
| Methylphenidate Hydrochloride Extended-Release | methylphenidate hydrochloride | capsule, extended release, oral | 0406-1820ANDA |
| Methylphenidate Hydrochloride Extended-Release | methylphenidate hydrochloride | capsule, extended release, oral | 0406-1830ANDA |
| Methylphenidate Hydrochloride Extended-Release | methylphenidate hydrochloride | capsule, extended release, oral | 0406-1840ANDA |
| Methylphenidate Hydrochloride Extended-Release | methylphenidate hydrochloride | capsule, extended release, oral | 0406-1850ANDA |
| Methylphenidate Hydrochloride Extended-Release | methylphenidate hydrochloride | capsule, extended release, oral | 0406-1860ANDA |
| Mixed Salts of a Single Entity Amphetamine Product XR | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate | capsule, extended release, oral | 0406-8951ANDA |
| Mixed Salts of a Single Entity Amphetamine Product XR | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate | capsule, extended release, oral | 0406-8952ANDA |
| Mixed Salts of a Single Entity Amphetamine Product XR | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate | capsule, extended release, oral | 0406-8953ANDA |
| Mixed Salts of a Single Entity Amphetamine Product XR | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate | capsule, extended release, oral | 0406-8954ANDA |
| Mixed Salts of a Single Entity Amphetamine Product XR | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate | capsule, extended release, oral | 0406-8955ANDA |
| Mixed Salts of a Single Entity Amphetamine Product XR | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate | capsule, extended release, oral | 0406-8956ANDA |
Neighbours
Registered in the same town
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- Haleon US Holdings LLCSt. Louis, MO
- Eisai Inc.Raleigh, NC
- Nice-Pak Products, LLCSt. Louis, MO
- Meridian Medical Technologies, LLCSt. Louis, MO
- Indivior Inc.Raleigh, NC
- LIEBEL-FLARSHEIM COMPANY LLC.Raleigh, NC
- Particle Dynamics dba CodisSt. Louis, MO
- Medwiser, Inc.St. Louis, MO
- Reliable Biopharmaceutical, LLCSt. Louis, MO
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Enquiry
Common questions
- Is SpecGx LLC FDA approved?
- SpecGx LLC holds 5 FDA-registered establishments in the United States. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
- Where are SpecGx LLC's drugs manufactured?
- The FDA register lists Greenville, IL; Hobart, NY; Raleigh, NC; St. Louis, MO; Webster Groves, MO. Registered operations: analytical testing, active ingredient (API) manufacture, distribute, finished drug manufacture, packaging, relabelling, repackaging.
- What drugs does SpecGx LLC make?
- 237 products are listed under SpecGx LLC in the openFDA NDC Directory, most often as powder; tablet; capsule. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
- Are any SpecGx LLC products in shortage?
- 13 presentations are currently listed in the FDA drug shortage database under SpecGx LLC, covering Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet, Lisdexamfetamine Dimesylate Capsule.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.