Register entryShortage reported
SpecGx LLC
- Registered sites
- 5
- Drug products
- 236
- Live patents
- 0
- Countries
- 1
- Base
- United States
Authorisation
Registered operations
What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.
Analytical testingActive ingredient (API) manufacturedistributeFinished drug manufacturePackagingRelabellingRepackaging
Sites
Facilities
5| Site | Location | Operations | FEI |
|---|---|---|---|
| SpecGx LLC | Greenville, ILUnited States | Analytical testing, Active ingredient (API) manufacture | 1419579 |
| SpecGx LLC | Hobart, NYUnited States | Analytical testing, distribute, Finished drug manufacture, Packaging, Relabelling, Repackaging | 1317295 |
| SpecGx LLC | Raleigh, NCUnited States | Analytical testing, Active ingredient (API) manufacture | 1021320 |
| SpecGx LLC | St. Louis, MOUnited States | Analytical testing, Active ingredient (API) manufacture | 1940521 |
| SpecGx LLC | Webster Groves, MOUnited States | Analytical testing, Finished drug manufacture | 3005275960 |
Alert
Products in shortage
13| Drug | Presentation | Availability |
|---|---|---|
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet | 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) | Available |
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet | 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) | Available |
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet | Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate, Tablet, 5 mg; 5 mg; 5 mg; 5 mg (NDC 0406-8893-01) | Available |
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet | 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) | Limited Availability |
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet | 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) | Limited Availability |
| Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet | 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) | Limited Availability |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 30 mg (NDC 0406-5113-01) | Available |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 70 mg (NDC 0406-5117-01) | Available |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 60 mg (NDC 0406-5116-01) | Available |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 40 mg (NDC 0406-5114-01) | Available |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 20 mg (NDC 0406-5112-01) | Available |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 10 mg (NDC 0406-5111-01) | Available |
| Lisdexamfetamine Dimesylate Capsule | Lisdexamfetamine Dimesylate, Capsule, 50 mg (NDC 0406-5115-01) | Available |
Catalogue
Marketed products
236Showing 150 of 236.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | TABLET | ANDA |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | TABLET | ANDA |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | acetaminophen and codeine phosphate | TABLET | ANDA |
| - | ACETAMINOPHEN ANHYDROUS BASIS | POWDER | DRUG FOR FURTHER PROCESSING |
| - | ACETAMINOPHEN ANHYDROUS BASIS | POWDER | DRUG FOR FURTHER PROCESSING |
| - | ACETAMINOPHEN ANHYDROUS BASIS | POWDER | DRUG FOR FURTHER PROCESSING |
| - | AMPHETAMINE ASPARTATE | POWDER | BULK INGREDIENT |
| - | AMPHETAMINE SULFATE | POWDER | BULK INGREDIENT |
| ANAFRANIL | clomipramine hydrochloride | CAPSULE | NDA |
| ANAFRANIL | clomipramine hydrochloride | CAPSULE | NDA |
| ANAFRANIL | clomipramine hydrochloride | CAPSULE | NDA |
| - | Acetaminophen Anhydrous Basis | POWDER | DRUG FOR FURTHER PROCESSING |
| - | Acetaminophen Anhydrous Basis | POWDER | DRUG FOR FURTHER PROCESSING |
| - | Acetaminophen Anhydrous Basis | POWDER | DRUG FOR FURTHER PROCESSING |
| - | Acetaminophen Anhydrous Basis | POWDER | DRUG FOR FURTHER PROCESSING |
| - | Acetaminophen Anhydrous Basis | POWDER | DRUG FOR FURTHER PROCESSING |
| - | Acetaminophen Anhydrous Basis / Paracetamol Ph Eur | POWDER | DRUG FOR FURTHER PROCESSING |
| - | Acetaminophen Anhydrous Basis And Chlorpheniramine Maleate | POWDER | DRUG FOR FURTHER PROCESSING |
| Amitiza | lubiprostone | CAPSULE, GELATIN COATED | NDA |
| Amitiza | lubiprostone | CAPSULE, GELATIN COATED | NDA |
| Amphetamine Sulfate | Amphetamine Sulfate | TABLET | ANDA |
| Amphetamine Sulfate | Amphetamine Sulfate | TABLET | ANDA |
| - | BUPRENORPHINE BASE | POWDER | BULK INGREDIENT |
| - | BUPRENORPHINE HYDROCHLORIDE | POWDER | BULK INGREDIENT |
| - | BUPRENORPHINE HYDROCHLORIDE | POWDER | BULK INGREDIENT |
| - | BUPRENORPHINE HYDROCHLORIDE | POWDER | BULK INGREDIENT |
| Buprenorphine HCl | Buprenorphine HCl | TABLET | ANDA |
| Buprenorphine HCl | Buprenorphine HCl | TABLET | ANDA |
| - | Buprenorphine Hydrochloride | POWDER | BULK INGREDIENT |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate | Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate | TABLET | ANDA |
| Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate | Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate | TABLET | ANDA |
| CLOMIPRAMINE HYDROCHLORIDE | clomipramine hydrochloride | CAPSULE | NDA |
| CLOMIPRAMINE HYDROCHLORIDE | clomipramine hydrochloride | CAPSULE | NDA |
| CLOMIPRAMINE HYDROCHLORIDE | clomipramine hydrochloride | CAPSULE | NDA |
| - | CODEINE PHOSPHATE | POWDER | BULK INGREDIENT |
| - | CODEINE SULFATE | POWDER | BULK INGREDIENT |
| - | Cocaine Hydrochloride | POWDER | BULK INGREDIENT |
| - | Codeine Phosphate | POWDER | BULK INGREDIENT |
| - | Codeine Phosphate | POWDER | BULK INGREDIENT |
| - | DEXTROAMPHETAMINE SACCHARATE | POWDER | BULK INGREDIENT |
| DEXTROAMPHETAMINE SULFATE | dextroamphetamine sulfate | TABLET | ANDA |
| DEXTROAMPHETAMINE SULFATE | dextroamphetamine sulfate | TABLET | ANDA |
| - | Dexmethylphenidate Hydrochloride | POWDER | BULK INGREDIENT |
| - | Dextroamphetamine Base | LIQUID | BULK INGREDIENT |
| - | Dextroamphetamine Saccharate Fine NP | POWDER | BULK INGREDIENT |
| - | Dextroamphetamine Saccharate NP | POWDER | BULK INGREDIENT |
| Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate | Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate | TABLET | ANDA |
| Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate | Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate | TABLET | ANDA |
| Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate | dextroamphetamine saccharate and amphetamine aspartate and dextroamphetamine sulfate and amphetamine sulfate | TABLET | ANDA |
| Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate | Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate | TABLET | ANDA |
| Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate | Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate | TABLET | ANDA |
| Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate | Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfate | TABLET | ANDA |
| Dextroamphetamine Sulfate Extended-Release | dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE | ANDA |
| Dextroamphetamine Sulfate Extended-Release | dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE | ANDA |
| Dextroamphetamine Sulfate Extended-Release | dextroamphetamine sulfate | CAPSULE, EXTENDED RELEASE | ANDA |
| - | Dextroamphetamine Sulfate Fine NP | POWDER | BULK INGREDIENT |
| - | Dextroamphetamine Sulfate NP | POWDER | BULK INGREDIENT |
| - | Dextromethadone Hydrochloride | POWDER | BULK INGREDIENT |
| - | Dextromethadone Hydrochloride | POWDER | BULK INGREDIENT |
| - | Diphenoxylate Hydrochloride | POWDER | BULK INGREDIENT |
| Diphenoxylate Hydrochloride and Atropine Sulfate | diphenoxylate hydrochloride and atropine sulfate | TABLET | ANDA |
| - | FENTANYL ALKALOID | POWDER | BULK INGREDIENT |
| - | FENTANYL CITRATE | POWDER | BULK INGREDIENT |
| - | FENTANYL CITRATE | POWDER | BULK INGREDIENT |
| FENTANYL TRANSDERMAL | fentanyl transdermal | PATCH, EXTENDED RELEASE | ANDA |
| FENTANYL TRANSDERMAL | fentanyl transdermal | PATCH, EXTENDED RELEASE | ANDA |
| FENTANYL TRANSDERMAL | fentanyl transdermal | PATCH, EXTENDED RELEASE | ANDA |
| FENTANYL TRANSDERMAL | fentanyl transdermal | PATCH, EXTENDED RELEASE | ANDA |
| FENTANYL TRANSDERMAL | fentanyl transdermal | PATCH, EXTENDED RELEASE | ANDA |
| FENTANYL TRANSDERMAL | fentanyl transdermal | PATCH, EXTENDED RELEASE | ANDA |
| FENTANYL TRANSDERMAL | fentanyl transdermal | PATCH, EXTENDED RELEASE | ANDA |
| - | Fentanyl Alkaloid | POWDER | BULK INGREDIENT |
| - | Fentanyl Citrate | POWDER | BULK INGREDIENT |
| - | Fentanyl Citrate | POWDER | BULK INGREDIENT |
| - | HYDROCODONE BITARTRATE | POWDER | BULK INGREDIENT |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | TABLET | ANDA |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | TABLET | ANDA |
| HYDROCODONE BITARTRATE AND ACETAMINOPHEN | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | TABLET | ANDA |
| - | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | TABLET | EXPORT ONLY |
| - | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | TABLET | EXPORT ONLY |
| - | HYDROCODONE BITARTRATE AND ACETAMINOPHEN | TABLET | EXPORT ONLY |
| - | HYDROMORPHONE HYDROCHLORIDE | POWDER | BULK INGREDIENT |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | TABLET | ANDA |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | TABLET | ANDA |
| Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate and Acetaminophen | TABLET | ANDA |
| Hydromorphone Hydrochloride | hydromorphone hydrochloride | TABLET | ANDA |
| Hydromorphone Hydrochloride | hydromorphone hydrochloride | TABLET | ANDA |
| Hydromorphone Hydrochloride | hydromorphone hydrochloride | TABLET | ANDA |
| - | IBUPROFEN | POWDER | DRUG FOR FURTHER PROCESSING |
| - | Ibuprofen | POWDER | DRUG FOR FURTHER PROCESSING |
| - | LEVORPHANOL TARTRATE | POWDER | BULK INGREDIENT |
| Levorphanol Tartrate | Levorphanol Tartrate | TABLET | ANDA |
| - | Lisdexamfetamine Dimesylate | POWDER | BULK INGREDIENT |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine Dimesylate | CAPSULE | ANDA |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine Dimesylate | CAPSULE | ANDA |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine Dimesylate | CAPSULE | ANDA |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine Dimesylate | CAPSULE | ANDA |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine Dimesylate | CAPSULE | ANDA |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine Dimesylate | CAPSULE | ANDA |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine Dimesylate | CAPSULE | ANDA |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine Dimesylate | TABLET, CHEWABLE | ANDA |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine Dimesylate | TABLET, CHEWABLE | ANDA |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine Dimesylate | TABLET, CHEWABLE | ANDA |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine Dimesylate | TABLET, CHEWABLE | ANDA |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine Dimesylate | TABLET, CHEWABLE | ANDA |
| Lisdexamfetamine Dimesylate | Lisdexamfetamine Dimesylate | TABLET, CHEWABLE | ANDA |
| Lubiprostone | Lubiprostone | CAPSULE, GELATIN COATED | NDA AUTHORIZED GENERIC |
| Lubiprostone | Lubiprostone | CAPSULE, GELATIN COATED | NDA AUTHORIZED GENERIC |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | TABLET | ANDA |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | TABLET | ANDA |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | TABLET | ANDA |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | SOLUTION | ANDA |
| METHADONE HYDROCHLORIDE | METHADONE HYDROCHLORIDE | SOLUTION | ANDA |
| METHADOSE | methadone hydrochloride | CONCENTRATE | NDA |
| METHADOSE DISPERSIBLE | Methadone Hydrochloride | TABLET | ANDA |
| METHADOSE SUGAR-FREE | methadone hydrochloride | CONCENTRATE | NDA |
| - | METHYLNALTREXONE BROMIDE | POWDER | BULK INGREDIENT |
| - | METHYLPHENIDATE | POWDER | BULK INGREDIENT |
| - | METHYLPHENIDATE HYDROCHLORIDE | POWDER | BULK INGREDIENT |
| - | METHYLPHENIDATE HYDROCHLORIDE | POWDER | BULK INGREDIENT |
| - | MORPHINE SULFATE | POWDER | BULK INGREDIENT |
| MORPHINE SULFATE | MORPHINE SULFATE | TABLET, EXTENDED RELEASE | ANDA |
| MORPHINE SULFATE | MORPHINE SULFATE | TABLET, EXTENDED RELEASE | ANDA |
| MORPHINE SULFATE | MORPHINE SULFATE | TABLET, EXTENDED RELEASE | ANDA |
| MORPHINE SULFATE | MORPHINE SULFATE | TABLET, EXTENDED RELEASE | ANDA |
| MORPHINE SULFATE | MORPHINE SULFATE | TABLET, EXTENDED RELEASE | ANDA |
| - | Methadone Hydrochloride | POWDER | BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING |
| Methadone Hydrochloride | Methadone Hydrochloride | CONCENTRATE | ANDA |
| - | Methadone Hydrochloride | POWDER | BULK INGREDIENT |
| - | Methadone Hydrochloride | POWDER | BULK INGREDIENT |
| Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | TABLET | ANDA |
| Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | TABLET | ANDA |
| Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | TABLET | ANDA |
| Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | TABLET, EXTENDED RELEASE | ANDA |
| Methylphenidate Hydrochloride | Methylphenidate Hydrochloride | TABLET, EXTENDED RELEASE | ANDA |
| Methylphenidate Hydrochloride Extended-Release | Methylphenidate Hydrochloride | TABLET, EXTENDED RELEASE | ANDA |
| Methylphenidate Hydrochloride Extended-Release | Methylphenidate Hydrochloride | TABLET, EXTENDED RELEASE | ANDA |
| Methylphenidate Hydrochloride Extended-Release | Methylphenidate Hydrochloride | TABLET, EXTENDED RELEASE | ANDA |
| Methylphenidate Hydrochloride Extended-Release | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE | ANDA |
| Methylphenidate Hydrochloride Extended-Release | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE | ANDA |
| Methylphenidate Hydrochloride Extended-Release | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE | ANDA |
| Methylphenidate Hydrochloride Extended-Release | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE | ANDA |
| Methylphenidate Hydrochloride Extended-Release | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE | ANDA |
| Methylphenidate Hydrochloride Extended-Release | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE | ANDA |
| Mixed Salts of a Single Entity Amphetamine Product XR | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate | CAPSULE, EXTENDED RELEASE | ANDA |
| Mixed Salts of a Single Entity Amphetamine Product XR | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate | CAPSULE, EXTENDED RELEASE | ANDA |
| Mixed Salts of a Single Entity Amphetamine Product XR | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate | CAPSULE, EXTENDED RELEASE | ANDA |
| Mixed Salts of a Single Entity Amphetamine Product XR | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate | CAPSULE, EXTENDED RELEASE | ANDA |
| Mixed Salts of a Single Entity Amphetamine Product XR | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate | CAPSULE, EXTENDED RELEASE | ANDA |
| Mixed Salts of a Single Entity Amphetamine Product XR | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate | CAPSULE, EXTENDED RELEASE | ANDA |
Provenance
Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.