Sigmapharm Laboratories, LLC
NDC labeler code: 42794
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
- Liothyronine sodiumCytomel, Liomny · 6 products
- Acitretin3 products
- GriseofulvinUltramicrosize Griseofulvin, Griseofulvin Microsize · 3 products
- DofetilideTikosyn · 3 products
- AsenapineSaphris, Secuado · 2 products
- AmbrisentanLetairis · 2 products
- FlucytosineAncobon · 2 products
- Disulfiram2 products
- Protriptyline hydrochloride2 products
- Adefovir dipivoxil1 product
- Amiloride1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| December 10, 2020 | ANDA206107 | Asenapine ASENAPINE MALEATE | Sigmapharm Labs LLC |
| April 10, 2019 | ANDA208354 | Ambrisentan AMBRISENTAN | Sigmapharm Labs LLC |
| March 26, 2018 | ANDA207746 | Dofetilide DOFETILIDE | Sigmapharm Labs LLC |
| May 22, 2015 | ANDA204633 | Acitretin ACITRETIN | Sigmapharm Labs LLC |
| August 29, 2013 | ANDA202051 | Adefovir dipivoxil ADEFOVIR DIPIVOXIL | Sigmapharm Labs LLC |
| November 29, 2012 | ANDA200295 | Liothyronine sodium LIOTHYRONINE SODIUM | Sigmapharm Labs LLC |
| October 22, 2012 | ANDA202482 | Griseofulvin GRISEOFULVIN | Sigmapharm Labs LLC |
| October 22, 2012 | ANDA202545 | Griseofulvin GRISEOFULVIN,ULTRAMICROSIZE | Sigmapharm Labs LLC |
| June 28, 2011 | ANDA201566 | Flucytosine FLUCYTOSINE | Sigmapharm Labs LLC |
| March 28, 2011 | ANDA091619 | Disulfiram DISULFIRAM | Sigmapharm Labs LLC |
| May 3, 2010 | ANDA090462 | Protriptyline hydrochloride PROTRIPTYLINE HYDROCHLORIDE | Sigmapharm Labs LLC |
| January 30, 2009 | ANDA079133 | Amiloride AMILORIDE HYDROCHLORIDE | Sigmapharm Labs LLC |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2021
-
April 19, 2021 · Class III · Terminated · D-0379-2021 · Asenapine
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10.
-
April 19, 2021 · Class III · Terminated · D-0380-2021 · Asenapine
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10
2014
-
April 22, 2014 · Class II · Terminated · D-1344-2014 · Liothyronine sodium
Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are being recalled due to the finding of a potential carryover of trace amounts of a previously manufactured product.
Liothyronine Sodium Tablets, USP 5 mcg, Rx Only, a) 100-count bottle NDC 42794-018-02 and b) 1000-count bottle NDC 42794-018-06, SigmaPharm Laboratories, LLC, Bensalem, Pa.
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).
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
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- All prescription drugs A to ZSearch by generic, brand or Spanish name
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