SpecGx LLC
NDC labeler codes: 0406, 23635, 63481
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfateAdderall, Mixed Salts of a Single Entity Amphetamine Product XR, Adderall XR · 16 products
- MethylphenidateMetadate Cd, Relexxii, Methylphenidate Hydrochloride Cd · 14 products
- Lisdexamfetamine dimesylateVyvanse, Arynta · 13 products
- Oxycodone hydrochlorideOxycontin, Roxybond, Roxicodone · 9 products
- Methadone hydrochlorideMethadone Hydrocloride Dye-Free, Sugar-Free, Unflavored, Methadose, Methadose Sugar-Free · 9 products
- Morphine sulfateMs Contin, Mitigo, Duramorph · 8 products
- TemazepamRestoril · 8 products
- FentanylFentanyl System · 7 products
- Hydrocodone bitartrate and acetaminophenNorco · 6 products
- Clomipramine hydrochlorideAnafranil · 6 products
- Oxycodone and acetaminophenEndocet, Prolate, Percocet · 6 products
- DextroamphetamineZenzedi, Xelstrym, Dexedrine Spansule · 5 products
- Nortriptyline hydrochloridePamelor · 4 products
- LubiprostoneAmitiza, Amitza · 4 products
- Acetaminophen and codeine phosphate3 products
- Hydromorphone hydrochlorideDilaudid · 3 products
- PrucaloprideMotegrity · 2 products
- AmphetamineAdzenys Xr-Odt, Dyanavel XR, Evekeo · 2 products
- BuprenorphineBelbuca, Brixadi, Buprenorphine Transdermal System · 2 products
- Buprenorphine and naloxoneZubsolv, Buprenorphine and Naloxone Sublingual Film, Suboxone · 2 products
- Diphenoxylate hydrochloride and atropine sulfateLomotil · 1 product
- Naltrexone hydrochloride1 product
- Levorphanol tartrate1 product
- PosaconazoleNoxafil · 1 product
FDA applications for these products
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| December 10, 2025 | ANDA218473 | Buprenorphine BUPRENORPHINE HYDROCHLORIDE | Specgx LLC |
| June 24, 2025 | ANDA219193 | Prucalopride PRUCALOPRIDE SUCCINATE | Specgx LLC |
| December 17, 2024 | ANDA218850 | Lisdexamfetamine dimesylate LISDEXAMFETAMINE DIMESYLATE | Specgx LLC |
| August 31, 2023 | ANDA211546 | Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | Specgx LLC |
| August 25, 2023 | ANDA211840 | Lisdexamfetamine dimesylate LISDEXAMFETAMINE DIMESYLATE | Specgx LLC |
| August 21, 2023 | ANDA215194 | Morphine sulfate MORPHINE SULFATE | Specgx LLC |
| May 10, 2022 | ANDA212226 | Posaconazole POSACONAZOLE | Specgx LLC |
| January 22, 2021 | ANDA213583 | Amphetamine AMPHETAMINE SULFATE | Specgx LLC |
| October 6, 2020 | ANDA213335 | Diphenoxylate hydrochloride and atropine sulfate DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | Specgx LLC |
| December 13, 2019 | ANDA212024 | Levorphanol tartrate LEVORPHANOL TARTRATE | Specgx LLC |
| October 2, 2019 | ANDA207537 | Methadone hydrochloride METHADONE HYDROCHLORIDE | Specgx LLC |
| August 22, 2019 | ANDA207368 | Methadone hydrochloride METHADONE HYDROCHLORIDE | Specgx LLC |
| April 22, 2019 | ANDA211547 | Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | Specgx LLC |
| April 30, 2018 | ANDA210758 | Oxycodone hydrochloride OXYCODONE HYDROCHLORIDE | Specgx LLC |
| December 13, 2017 | ANDA207000 | Buprenorphine and naloxone BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE | Specgx LLC |
| March 31, 2017 | ANDA206718 | Hydrocodone bitartrate and acetaminophen HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Specgx LLC |
| September 29, 2015 | ANDA203583 | Methylphenidate METHYLPHENIDATE HYDROCHLORIDE | Specgx LLC |
| December 28, 2012 | ANDA202608 | Methylphenidate METHYLPHENIDATE HYDROCHLORIDE | Specgx LLC |
| July 15, 2011 | ANDA202348 | Morphine sulfate MORPHINE SULFATE | Specgx LLC |
| February 9, 2011 | ANDA077154 | Fentanyl FENTANYL-100, FENTANYL-12, FENTANYL-25 | Specgx LLC |
| January 31, 2006 | NDA021908 | Lubiprostone AMITIZA | Sucampo Pharma LLC |
| July 12, 2005 | ANDA077142 | Methadone hydrochloride METHADONE HYDROCHLORIDE | Specgx LLC |
| December 23, 2004 | ANDA076855 | Hydromorphone hydrochloride HYDROMORPHONE HYDROCHLORIDE | Specgx LLC |
| June 30, 2004 | ANDA040545 | Oxycodone and acetaminophen OXYCODONE AND ACETAMINOPHEN | Specgx LLC |
| June 30, 2004 | ANDA076758 | Oxycodone hydrochloride OXYCODONE HYDROCHLORIDE | Specgx LLC |
| April 27, 2004 | ANDA040517 | Methadone hydrochloride METHADONE HYDROCHLORIDE | Specgx LLC |
| October 7, 2003 | ANDA040440 | Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE | Specgx LLC |
| July 31, 2003 | ANDA076412 | Morphine sulfate MORPHINE SULFATE | Specgx LLC |
| July 3, 2003 | ANDA076438 | Morphine sulfate MORPHINE SULFATE | Specgx LLC |
| May 6, 2003 | ANDA076353 | Dextroamphetamine DEXTROAMPHETAMINE SULFATE | Specgx LLC |
| March 22, 2002 | ANDA076264 | Naltrexone hydrochloride NALTREXONE HYDROCHLORIDE | Specgx LLC |
| January 29, 2002 | ANDA040436 | Dextroamphetamine DEXTROAMPHETAMINE SULFATE | Specgx LLC |
| May 31, 2001 | ANDA040419 | Acetaminophen and codeine phosphate ACETAMINOPHEN AND CODEINE PHOSPHATE | Specgx LLC |
| October 20, 2000 | ANDA040409 | Hydrocodone bitartrate and acetaminophen ANEXSIA 5/325 | Specgx LLC |
| September 8, 2000 | ANDA040405 | Hydrocodone bitartrate and acetaminophen ANEXSIA 7.5/325 | Specgx LLC |
| August 31, 2000 | NDA021011 | Oxycodone hydrochloride ROXICODONE | Specgx LLC |
| July 26, 2000 | ANDA040400 | Hydrocodone bitartrate and acetaminophen HYDROCODONE BITARTRATE AND ACETAMINOPHEN | Specgx LLC |
| May 9, 2000 | ANDA075629 | Methylphenidate METHYLIN ER | Specgx LLC |
| June 25, 1999 | ANDA040330 | Oxycodone and acetaminophen PERCOCET | Ozantri |
| November 27, 1998 | ANDA040300 | Methylphenidate METHYLPHENIDATE HYDROCHLORIDE | Specgx LLC |
| April 29, 1993 | ANDA074184 | Methadone hydrochloride METHADOSE | Specgx LLC |
| December 29, 1989 | NDA019906 | Clomipramine hydrochloride ANAFRANIL | Specgx LLC |
| December 7, 1983 | ANDA087463 | Oxycodone and acetaminophen OXYCET | Specgx LLC |
| February 27, 1981 | NDA018163 | Temazepam RESTORIL | Specgx LLC |
| August 1, 1977 | NDA018013 | Nortriptyline hydrochloride PAMELOR | Specgx LLC |
| March 14, 1973 | NDA017116 | Methadone hydrochloride METHADOSE | Specgx LLC |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2025
-
December 16, 2025 · Class II · Ongoing · D-0254-2026 · Oxycodone and acetaminophen
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0523-01.
-
December 16, 2025 · Class II · Ongoing · D-0255-2026 · Oxycodone and acetaminophen
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0522-01. Case label: SpecGx LLC, NDC 0406052201, Exp. 2027/03, Lot: 0522J23493
2022
-
April 13, 2022 · Class II · Terminated · D-1039-2022 · Naltrexone hydrochloride
cGMP deviations: Temperature abuse
Naltrexone Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, MFG: Mallinckrodt Inc., NDC 0406-1170-03
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026