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
SiteLocationOperationsFEI
SpecGx LLCGreenville, ILUnited StatesAnalytical testing, Active ingredient (API) manufacture1419579
SpecGx LLCHobart, NYUnited StatesAnalytical testing, distribute, Finished drug manufacture, Packaging, Relabelling, Repackaging1317295
SpecGx LLCRaleigh, NCUnited StatesAnalytical testing, Active ingredient (API) manufacture1021320
SpecGx LLCSt. Louis, MOUnited StatesAnalytical testing, Active ingredient (API) manufacture1940521
SpecGx LLCWebster Groves, MOUnited StatesAnalytical testing, Finished drug manufacture3005275960
Alert

Products in shortage

13
DrugPresentationAvailability
Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate TabletAmphetamine 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 TabletAmphetamine 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 TabletAmphetamine 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 TabletAmphetamine 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 TabletAmphetamine 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 TabletAmphetamine 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 CapsuleLisdexamfetamine Dimesylate, Capsule, 30 mg (NDC 0406-5113-01)Available
Lisdexamfetamine Dimesylate CapsuleLisdexamfetamine Dimesylate, Capsule, 70 mg (NDC 0406-5117-01)Available
Lisdexamfetamine Dimesylate CapsuleLisdexamfetamine Dimesylate, Capsule, 60 mg (NDC 0406-5116-01)Available
Lisdexamfetamine Dimesylate CapsuleLisdexamfetamine Dimesylate, Capsule, 40 mg (NDC 0406-5114-01)Available
Lisdexamfetamine Dimesylate CapsuleLisdexamfetamine Dimesylate, Capsule, 20 mg (NDC 0406-5112-01)Available
Lisdexamfetamine Dimesylate CapsuleLisdexamfetamine Dimesylate, Capsule, 10 mg (NDC 0406-5111-01)Available
Lisdexamfetamine Dimesylate CapsuleLisdexamfetamine Dimesylate, Capsule, 50 mg (NDC 0406-5115-01)Available
Catalogue

Marketed products

236

Showing 150 of 236.

BrandGeneric nameFormCategory
ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateTABLETANDA
ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateTABLETANDA
ACETAMINOPHEN AND CODEINE PHOSPHATEacetaminophen and codeine phosphateTABLETANDA
-ACETAMINOPHEN ANHYDROUS BASISPOWDERDRUG FOR FURTHER PROCESSING
-ACETAMINOPHEN ANHYDROUS BASISPOWDERDRUG FOR FURTHER PROCESSING
-ACETAMINOPHEN ANHYDROUS BASISPOWDERDRUG FOR FURTHER PROCESSING
-AMPHETAMINE ASPARTATEPOWDERBULK INGREDIENT
-AMPHETAMINE SULFATEPOWDERBULK INGREDIENT
ANAFRANILclomipramine hydrochlorideCAPSULENDA
ANAFRANILclomipramine hydrochlorideCAPSULENDA
ANAFRANILclomipramine hydrochlorideCAPSULENDA
-Acetaminophen Anhydrous BasisPOWDERDRUG FOR FURTHER PROCESSING
-Acetaminophen Anhydrous BasisPOWDERDRUG FOR FURTHER PROCESSING
-Acetaminophen Anhydrous BasisPOWDERDRUG FOR FURTHER PROCESSING
-Acetaminophen Anhydrous BasisPOWDERDRUG FOR FURTHER PROCESSING
-Acetaminophen Anhydrous BasisPOWDERDRUG FOR FURTHER PROCESSING
-Acetaminophen Anhydrous Basis / Paracetamol Ph EurPOWDERDRUG FOR FURTHER PROCESSING
-Acetaminophen Anhydrous Basis And Chlorpheniramine MaleatePOWDERDRUG FOR FURTHER PROCESSING
AmitizalubiprostoneCAPSULE, GELATIN COATEDNDA
AmitizalubiprostoneCAPSULE, GELATIN COATEDNDA
Amphetamine SulfateAmphetamine SulfateTABLETANDA
Amphetamine SulfateAmphetamine SulfateTABLETANDA
-BUPRENORPHINE BASEPOWDERBULK INGREDIENT
-BUPRENORPHINE HYDROCHLORIDEPOWDERBULK INGREDIENT
-BUPRENORPHINE HYDROCHLORIDEPOWDERBULK INGREDIENT
-BUPRENORPHINE HYDROCHLORIDEPOWDERBULK INGREDIENT
Buprenorphine HClBuprenorphine HClTABLETANDA
Buprenorphine HClBuprenorphine HClTABLETANDA
-Buprenorphine HydrochloridePOWDERBULK INGREDIENT
Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBuprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateTABLETANDA
Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBuprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateTABLETANDA
CLOMIPRAMINE HYDROCHLORIDEclomipramine hydrochlorideCAPSULENDA
CLOMIPRAMINE HYDROCHLORIDEclomipramine hydrochlorideCAPSULENDA
CLOMIPRAMINE HYDROCHLORIDEclomipramine hydrochlorideCAPSULENDA
-CODEINE PHOSPHATEPOWDERBULK INGREDIENT
-CODEINE SULFATEPOWDERBULK INGREDIENT
-Cocaine HydrochloridePOWDERBULK INGREDIENT
-Codeine PhosphatePOWDERBULK INGREDIENT
-Codeine PhosphatePOWDERBULK INGREDIENT
-DEXTROAMPHETAMINE SACCHARATEPOWDERBULK INGREDIENT
DEXTROAMPHETAMINE SULFATEdextroamphetamine sulfateTABLETANDA
DEXTROAMPHETAMINE SULFATEdextroamphetamine sulfateTABLETANDA
-Dexmethylphenidate HydrochloridePOWDERBULK INGREDIENT
-Dextroamphetamine BaseLIQUIDBULK INGREDIENT
-Dextroamphetamine Saccharate Fine NPPOWDERBULK INGREDIENT
-Dextroamphetamine Saccharate NPPOWDERBULK INGREDIENT
Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine SulfateTABLETANDA
Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine SulfateTABLETANDA
Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine Sulfatedextroamphetamine saccharate and amphetamine aspartate and dextroamphetamine sulfate and amphetamine sulfateTABLETANDA
Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine SulfateTABLETANDA
Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine SulfateTABLETANDA
Dextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate and Amphetamine Aspartate and Dextroamphetamine Sulfate and Amphetamine SulfateTABLETANDA
Dextroamphetamine Sulfate Extended-Releasedextroamphetamine sulfateCAPSULE, EXTENDED RELEASEANDA
Dextroamphetamine Sulfate Extended-Releasedextroamphetamine sulfateCAPSULE, EXTENDED RELEASEANDA
Dextroamphetamine Sulfate Extended-Releasedextroamphetamine sulfateCAPSULE, EXTENDED RELEASEANDA
-Dextroamphetamine Sulfate Fine NPPOWDERBULK INGREDIENT
-Dextroamphetamine Sulfate NPPOWDERBULK INGREDIENT
-Dextromethadone HydrochloridePOWDERBULK INGREDIENT
-Dextromethadone HydrochloridePOWDERBULK INGREDIENT
-Diphenoxylate HydrochloridePOWDERBULK INGREDIENT
Diphenoxylate Hydrochloride and Atropine Sulfatediphenoxylate hydrochloride and atropine sulfateTABLETANDA
-FENTANYL ALKALOIDPOWDERBULK INGREDIENT
-FENTANYL CITRATEPOWDERBULK INGREDIENT
-FENTANYL CITRATEPOWDERBULK INGREDIENT
FENTANYL TRANSDERMALfentanyl transdermalPATCH, EXTENDED RELEASEANDA
FENTANYL TRANSDERMALfentanyl transdermalPATCH, EXTENDED RELEASEANDA
FENTANYL TRANSDERMALfentanyl transdermalPATCH, EXTENDED RELEASEANDA
FENTANYL TRANSDERMALfentanyl transdermalPATCH, EXTENDED RELEASEANDA
FENTANYL TRANSDERMALfentanyl transdermalPATCH, EXTENDED RELEASEANDA
FENTANYL TRANSDERMALfentanyl transdermalPATCH, EXTENDED RELEASEANDA
FENTANYL TRANSDERMALfentanyl transdermalPATCH, EXTENDED RELEASEANDA
-Fentanyl AlkaloidPOWDERBULK INGREDIENT
-Fentanyl CitratePOWDERBULK INGREDIENT
-Fentanyl CitratePOWDERBULK INGREDIENT
-HYDROCODONE BITARTRATEPOWDERBULK INGREDIENT
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENTABLETANDA
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENTABLETANDA
HYDROCODONE BITARTRATE AND ACETAMINOPHENHYDROCODONE BITARTRATE AND ACETAMINOPHENTABLETANDA
-HYDROCODONE BITARTRATE AND ACETAMINOPHENTABLETEXPORT ONLY
-HYDROCODONE BITARTRATE AND ACETAMINOPHENTABLETEXPORT ONLY
-HYDROCODONE BITARTRATE AND ACETAMINOPHENTABLETEXPORT ONLY
-HYDROMORPHONE HYDROCHLORIDEPOWDERBULK INGREDIENT
Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTABLETANDA
Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTABLETANDA
Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and AcetaminophenTABLETANDA
Hydromorphone Hydrochloridehydromorphone hydrochlorideTABLETANDA
Hydromorphone Hydrochloridehydromorphone hydrochlorideTABLETANDA
Hydromorphone Hydrochloridehydromorphone hydrochlorideTABLETANDA
-IBUPROFENPOWDERDRUG FOR FURTHER PROCESSING
-IbuprofenPOWDERDRUG FOR FURTHER PROCESSING
-LEVORPHANOL TARTRATEPOWDERBULK INGREDIENT
Levorphanol TartrateLevorphanol TartrateTABLETANDA
-Lisdexamfetamine DimesylatePOWDERBULK INGREDIENT
Lisdexamfetamine DimesylateLisdexamfetamine DimesylateCAPSULEANDA
Lisdexamfetamine DimesylateLisdexamfetamine DimesylateCAPSULEANDA
Lisdexamfetamine DimesylateLisdexamfetamine DimesylateCAPSULEANDA
Lisdexamfetamine DimesylateLisdexamfetamine DimesylateCAPSULEANDA
Lisdexamfetamine DimesylateLisdexamfetamine DimesylateCAPSULEANDA
Lisdexamfetamine DimesylateLisdexamfetamine DimesylateCAPSULEANDA
Lisdexamfetamine DimesylateLisdexamfetamine DimesylateCAPSULEANDA
Lisdexamfetamine DimesylateLisdexamfetamine DimesylateTABLET, CHEWABLEANDA
Lisdexamfetamine DimesylateLisdexamfetamine DimesylateTABLET, CHEWABLEANDA
Lisdexamfetamine DimesylateLisdexamfetamine DimesylateTABLET, CHEWABLEANDA
Lisdexamfetamine DimesylateLisdexamfetamine DimesylateTABLET, CHEWABLEANDA
Lisdexamfetamine DimesylateLisdexamfetamine DimesylateTABLET, CHEWABLEANDA
Lisdexamfetamine DimesylateLisdexamfetamine DimesylateTABLET, CHEWABLEANDA
LubiprostoneLubiprostoneCAPSULE, GELATIN COATEDNDA AUTHORIZED GENERIC
LubiprostoneLubiprostoneCAPSULE, GELATIN COATEDNDA AUTHORIZED GENERIC
METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDETABLETANDA
METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDETABLETANDA
METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDETABLETANDA
METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDESOLUTIONANDA
METHADONE HYDROCHLORIDEMETHADONE HYDROCHLORIDESOLUTIONANDA
METHADOSEmethadone hydrochlorideCONCENTRATENDA
METHADOSE DISPERSIBLEMethadone HydrochlorideTABLETANDA
METHADOSE SUGAR-FREEmethadone hydrochlorideCONCENTRATENDA
-METHYLNALTREXONE BROMIDEPOWDERBULK INGREDIENT
-METHYLPHENIDATEPOWDERBULK INGREDIENT
-METHYLPHENIDATE HYDROCHLORIDEPOWDERBULK INGREDIENT
-METHYLPHENIDATE HYDROCHLORIDEPOWDERBULK INGREDIENT
-MORPHINE SULFATEPOWDERBULK INGREDIENT
MORPHINE SULFATEMORPHINE SULFATETABLET, EXTENDED RELEASEANDA
MORPHINE SULFATEMORPHINE SULFATETABLET, EXTENDED RELEASEANDA
MORPHINE SULFATEMORPHINE SULFATETABLET, EXTENDED RELEASEANDA
MORPHINE SULFATEMORPHINE SULFATETABLET, EXTENDED RELEASEANDA
MORPHINE SULFATEMORPHINE SULFATETABLET, EXTENDED RELEASEANDA
-Methadone HydrochloridePOWDERBULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING
Methadone HydrochlorideMethadone HydrochlorideCONCENTRATEANDA
-Methadone HydrochloridePOWDERBULK INGREDIENT
-Methadone HydrochloridePOWDERBULK INGREDIENT
Methylphenidate HydrochlorideMethylphenidate HydrochlorideTABLETANDA
Methylphenidate HydrochlorideMethylphenidate HydrochlorideTABLETANDA
Methylphenidate HydrochlorideMethylphenidate HydrochlorideTABLETANDA
Methylphenidate HydrochlorideMethylphenidate HydrochlorideTABLET, EXTENDED RELEASEANDA
Methylphenidate HydrochlorideMethylphenidate HydrochlorideTABLET, EXTENDED RELEASEANDA
Methylphenidate Hydrochloride Extended-ReleaseMethylphenidate HydrochlorideTABLET, EXTENDED RELEASEANDA
Methylphenidate Hydrochloride Extended-ReleaseMethylphenidate HydrochlorideTABLET, EXTENDED RELEASEANDA
Methylphenidate Hydrochloride Extended-ReleaseMethylphenidate HydrochlorideTABLET, EXTENDED RELEASEANDA
Methylphenidate Hydrochloride Extended-Releasemethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASEANDA
Methylphenidate Hydrochloride Extended-Releasemethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASEANDA
Methylphenidate Hydrochloride Extended-Releasemethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASEANDA
Methylphenidate Hydrochloride Extended-Releasemethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASEANDA
Methylphenidate Hydrochloride Extended-Releasemethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASEANDA
Methylphenidate Hydrochloride Extended-Releasemethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASEANDA
Mixed Salts of a Single Entity Amphetamine Product XRDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine SulfateCAPSULE, EXTENDED RELEASEANDA
Mixed Salts of a Single Entity Amphetamine Product XRDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine SulfateCAPSULE, EXTENDED RELEASEANDA
Mixed Salts of a Single Entity Amphetamine Product XRDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine SulfateCAPSULE, EXTENDED RELEASEANDA
Mixed Salts of a Single Entity Amphetamine Product XRDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine SulfateCAPSULE, EXTENDED RELEASEANDA
Mixed Salts of a Single Entity Amphetamine Product XRDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine SulfateCAPSULE, EXTENDED RELEASEANDA
Mixed Salts of a Single Entity Amphetamine Product XRDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine SulfateCAPSULE, EXTENDED RELEASEANDA
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.