Nivagen Pharmaceuticals, Inc.
NDC labeler code: 75834
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
- TemozolomideTemodar · 6 products
- TadalafilCialis, Tadliq, Adcirca · 4 products
- CelecoxibCelebrex, Vyscoxa, Elyxyb - Celecoxib · 4 products
- GlycopyrrolateGlyrx-Pf, Glycate, Cuvposa · 4 products
- AtorvastatinLipitor · 4 products
- Verapamil hydrochloride3 products
- Venlafaxine hydrochlorideEffexor XR · 3 products
- MethylphenidateMetadate Cd, Relexxii, Methylphenidate Hydrochloride Cd · 3 products
- SildenafilViagra, Vybrique, Revatio · 3 products
- Diclofenac sodium and misoprostolArthrotec, Dicloenac Sodium and Misoprostol DR · 2 products
- Dexmethylphenidate hydrochlorideFocalin XR, Focalin · 2 products
- DiclofenacZipsor, Lofena, Cambia · 2 products
- Erythromycin ethylsuccinateEry-Ped, E.E.S 400, E.E.S · 2 products
- ChlorthalidoneThalitone, Hemiclor · 2 products
- CarbamazepineTegretol XR, Equetro, Carbatrol · 2 products
- Decitabine1 product
- Calcium acetate1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| August 29, 2025 | ANDA217010 | Diclofenac DICLOFENAC POTASSIUM | Umedica |
| March 13, 2023 | ANDA217205 | Calcium acetate CALCIUM ACETATE | Adaptis |
| November 21, 2022 | ANDA216212 | Erythromycin ethylsuccinate ERYTHROMYCIN ETHYLSUCCINATE | Cadila Pharms Ltd |
| May 11, 2022 | ANDA215750 | Diclofenac DICLOFENAC POTASSIUM | Umedica |
| November 23, 2021 | ANDA213328 | Temozolomide TEMOZOLOMIDE | Nivagen |
| October 13, 2021 | ANDA212591 | Glycopyrrolate GLYCOPYRROLATE | Nivagen |
| December 7, 2020 | ANDA212117 | Decitabine DECITABINE | Nivagen |
| October 23, 2020 | ANDA211298 | Tadalafil TADALAFIL | Umedica |
| August 25, 2020 | ANDA209302 | Sildenafil SILDENAFIL CITRATE | Umedica |
| August 19, 2020 | ANDA213853 | Atorvastatin ATORVASTATIN CALCIUM | Umedica |
| April 15, 2020 | ANDA207798 | Carbamazepine CARBAMAZEPINE | Umedica |
| February 19, 2020 | ANDA205143 | Diclofenac sodium and misoprostol DICLOFENAC SODIUM AND MISOPROSTOL | Yung Shin Pharm |
| November 27, 2019 | ANDA210628 | Celecoxib CELECOXIB | Pharmazone |
| August 29, 2019 | ANDA211323 | Venlafaxine hydrochloride VENLAFAXINE HYDROCHLORIDE | Cadila Pharms Ltd |
| February 1, 2019 | ANDA208737 | Methylphenidate METHYLPHENIDATE HYDROCHLORIDE | Cediprof Inc |
| September 19, 2018 | ANDA209211 | Dexmethylphenidate hydrochloride DEXMETHYLPHENIDATE HYDROCHLORIDE | Cediprof Inc |
| May 24, 2018 | ANDA207222 | Chlorthalidone CHLORTHALIDONE | Umedica |
| May 5, 2017 | ANDA206173 | Verapamil hydrochloride VERAPAMIL HYDROCHLORIDE | Cadila Pharms Ltd |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2024
-
September 24, 2024 · Class II · Terminated · D-0001-2025 · Atorvastatin
Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.
Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Umedica Laboratories Pvt Ltd., Vapi Gujarat 396195, I
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