Labeler · US market

SpecGx LLC

SpecGx LLC is a US drug labeler with US FDA registrations covering 83 drug concepts (82 currently active) across 482 packages. It is currently the only active US supplier of 20 drugs.

ACTIVE — US

openFDA · updated weekly

Labeler codes0406 · 23635

Active drugs82

Registrations225 active / 232

Packages482

Sole supplier of20 drugs

Portfolio83 drugs · US

Every drug concept this labeler has US registrations for, by package count.

Drug	Type	NDCs	Packages	Status
Hydrocodone Bitartrate And Acetaminophen tablet	rx	6	21	SUPPLYING
Oxycodone Hydrochloride tablet	rx	7	17	SUPPLYING
Methadone Hydrochloride powder	other	3	17	SUPPLYING
Paracetamol powder	other	15	16	SUPPLYING
Acetaminophen Anhydrous Basis powder	other	9	16	SUPPLYING
Codeine Phosphate powder	other	3	15	SUPPLYING
Fentanyl Citrate powder	other	4	15	SUPPLYING
Morphine Sulfate powder	other	2	14	SUPPLYING
Oxycodone Hydrochloride And Acetaminophen tablet	rx	3	13	SUPPLYING
Morphine Sulfate tablet, extended release	rx	5	13	SUPPLYING
Acetaminophen powder	other	12	12	SUPPLYING
Buprenorphine Hydrochloride powder	other	3	11	SUPPLYING
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate capsule, extended release	rx	10	10	SUPPLYING
Noscapine powder	other	2	10	SUPPLYING
Methylphenidate Hydrochloride powder	other	2	9	SUPPLYING
Temazepam capsule	rx	8	9	SUPPLYING
Methadone Hydrochloride tablet	rx	4	8	SUPPLYING
Acetaminophen And Codeine Phosphate tablet	rx	3	8	SUPPLYING
Fentanyl Alkaloid powder	other	2	8	SUPPLYING
Hydromorphone Hydrochloride powder	other	1	7	SUPPLYING
Fentanyl Transdermal patch, extended release	rx	7	7	SUPPLYING
Oxycodone Hydrochloride D powder	other	1	7	SUPPLYING
Lisdexamfetamine Dimesylate capsule	rx	7	7	SUPPLYING
Oxycodone Hcl Low - Alpha Beta Unsaturated Ketone powder	other	1	7	SUPPLYING
Lisdexamfetamine Dimesylate tablet, chewable	rx	6	6	SUPPLYING
Diphenoxylate Hydrochloride powder	other	2	6	SUPPLYING
Cocaine Hydrochloride powder	other	1	6	SUPPLYING
Methylphenidate Hydrochloride tablet	rx	3	6	SUPPLYING
Clomipramine Hydrochloride capsule	rx	6	6	SUPPLYING
Sufentanil Citrate powder	other	2	6	SUPPLYING
Methylphenidate Hydrochloride capsule, extended release	rx	6	6	SUPPLYING
Hydrocodone Bitartrate powder	other	1	6	SUPPLYING
Dextromethadone Hydrochloride powder	other	2	6	SUPPLYING
Dextroamphetamine Saccharate And Amphetamine Aspartate And Dextroamphetamine Sulfate And Amphetamine Sulfate tablet	rx	6	6	SUPPLYING
Methylphenidate Hydrochloride tablet, extended release	rx	5	5	SUPPLYING
Meperidine Hydrochloride powder	other	1	5	SUPPLYING
Naloxone Hydrochloride Dihydrate powder	other	1	5	SUPPLYING
Dexmethylphenidate Hydrochloride powder	other	1	5	SUPPLYING
Methadone Hydrochloride concentrate	rx	3	4	SUPPLYING
Morphine Sulfate solution	rx	1	4	SUPPLYING

Showing 40 of 83 drugs by package count.

Sole US supplier

Drugs where this labeler is currently the only active US supplier — a single point of failure if it exits.

+10 more

At a glance

TypeLabeler
Labeler codes0406, 23635
Filing names1
Drugs (active)82
Drugs (all time)83
US registrations232
Packages482

Recent events

Shortages, recalls, and registration changes across all filing names.

Feb 11, 2026
RESOLVEDShortage resolved: Naltrexone Hydrochloride Tablet (SpecGx LLC)
Dec 16, 2025
RECALLRecall (Class II): Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119,…
Dec 16, 2025
RECALLRecall (Class II): Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, N…
Feb 29, 2024
SHORTAGEDrug shortage: Naltrexone Hydrochloride Tablet (SpecGx LLC)
Jul 14, 2023
SHORTAGEDrug shortage: Lisdexamfetamine Dimesylate Capsule (SpecGx LLC)
Oct 12, 2022
SHORTAGEDrug shortage: Amphetamine Aspartate Monohydrate, Amphetamine Sulfate, Dextroamphetamine Saccharate, Dextroamphetamine Sulfate Tablet (SpecGx LLC)
Apr 13, 2022
RECALLRecall (Class II): Naltrexone Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, MFG: Mallinckrodt Inc., NDC 0406-1170-03

Watch this company

Alerts for recalls, exits, and new registrations.

Facility locations, FDA inspections, and parent-company mapping are on the roadmap. Name variants reported to FDA under different spellings are merged into this profile; figures cover the entity across all its filing names.