Labeler · US market

SIGMAPHARM LABORATORIES, LLC

SIGMAPHARM LABORATORIES, LLC is a US drug labeler with US FDA registrations covering 12 drug concepts (12 currently active) across 50 packages. It is currently the only active US supplier of 1 drug.

ACTIVE — US

openFDA · updated weekly

Labeler codes42794

Active drugs12

Registrations27 active / 27

Packages50

Sole supplier of1 drugs

Portfolio12 drugs · US

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

Drug	Type	NDCs	Packages	Status
Liothyronine Sodium tablet	rx	6	23	SUPPLYING
Asenapine tablet	rx	2	6	SUPPLYING
Ambrisentan tablet, film coated	rx	2	4	SUPPLYING
Dofetilide capsule	rx	3	3	SUPPLYING
Acitretin capsule	rx	3	3	SUPPLYING
Disulfiram tablet	rx	2	2	SUPPLYING
Flucytosine capsule	rx	2	2	SUPPLYING
Protriptyline Hydrochloride tablet, film coated	rx	2	2	SUPPLYING
Ultramicrosize Griseofulvin tablet	rx	2	2	SUPPLYING
Adefovir Dipivoxil tablet	rx	1	1	SUPPLYING
Amiloride Hydrochloride tablet	rx	1	1	SUPPLYING
Griseofulvin tablet	rx	1	1	SUPPLYING

Sole US supplier

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

Adefovir Dipivoxilrx

At a glance

TypeLabeler
Labeler codes42794
Filing names1
Drugs (active)12
Drugs (all time)12
US registrations27
Packages50

Recent events

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

Sep 21, 2021
RECALLRecall (Class II): Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton…
Aug 13, 2021
RECALLRecall (Class II): Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-…
Apr 19, 2021
RECALLRecall (Class III): Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 4279…
Apr 19, 2021
RECALLRecall (Class III): Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794…
Apr 22, 2014
RECALLRecall (Class II): Liothyronine Sodium Tablets, USP 5 mcg, Rx Only, a) 100-count bottle NDC 42794-018-02 and b) 1000-count bottle NDC 4279…

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.