Labeler · US market

Nivagen Pharmaceuticals, Inc.

Nivagen Pharmaceuticals, Inc. is a US drug labeler with US FDA registrations covering 43 drug concepts (43 currently active) across 215 packages. It is currently the only active US supplier of 2 drugs.

ACTIVE — US

openFDA · updated weekly

Labeler codes75834

Active drugs43

Registrations106 active / 106

Packages215

Sole supplier of2 drugs

Portfolio43 drugs · US

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

Drug	Type	NDCs	Packages	Status
Ofloxacin tablet, coated	rx	6	18	SUPPLYING
Atorvastatin Calcium tablet	rx	4	16	SUPPLYING
Celecoxib capsule	rx	4	12	SUPPLYING
Tadalafil tablet, film coated	rx	4	12	SUPPLYING
Temozolomide capsule	rx	6	11	SUPPLYING
Sildenafil Citrate tablet	rx	3	11	SUPPLYING
Buspirone Hydrochloride tablet	rx	5	9	SUPPLYING
Venlafaxine Hydrochloride tablet, extended release	rx	3	9	SUPPLYING
Metoprolol Succinate tablet, extended release	other	2	8	SUPPLYING
Metoprolol Succinate tablet, extended release	rx	2	8	SUPPLYING
Thyroid, Porcine tablet	rx	8	8	SUPPLYING
Rivastigmine Tartrate capsule	rx	4	8	SUPPLYING
Verapamil Hydrochloride tablet, film coated, extended release	rx	3	6	SUPPLYING
Glyburide tablet	rx	3	6	SUPPLYING
Hydralazine Hydrochloride tablet	rx	3	6	SUPPLYING
Acyclovir tablet	rx	2	4	SUPPLYING
Chlorthalidone tablet	rx	2	4	SUPPLYING
Carbamazepine tablet	rx	2	4	SUPPLYING
Norethindrone Acetate And Ethinyl Estradiol tablet	rx	2	4	SUPPLYING
Glycopyrrolate injection	rx	4	4	SUPPLYING
Erythromycin tablet, film coated	rx	2	4	SUPPLYING
Varenicline tablet, film coated	rx	2	3	SUPPLYING
Diclofenac Sodium And Misoprostol tablet, delayed release	rx	2	3	SUPPLYING
Tizanidine Hydrochloride capsule	rx	3	3	SUPPLYING
Gemfibrozil tablet	rx	1	3	SUPPLYING
Zinc Oxide ointment	otc	1	3	SUPPLYING
Methylphenidate Hydrochloride tablet	rx	3	3	SUPPLYING
Hydrocortisone Acetate suppository	rx	1	2	SUPPLYING
Erythromycin Ethylsuccinate suspension	rx	2	2	SUPPLYING
Potassium Iodide solution	rx	1	2	SUPPLYING
Diclofenac Potassium powder, for solution	rx	1	2	SUPPLYING
Diclofenac Potassium Tablets tablet, film coated	rx	1	2	SUPPLYING
Nateglinide tablet, coated	rx	2	2	SUPPLYING
Dexmethylphenidate Hydrochloride tablet	rx	2	2	SUPPLYING
Albuterol Sulfate tablet	rx	2	2	SUPPLYING
Acyclovir capsule	rx	1	2	SUPPLYING
Pramoxine Hydrochloride And Hydrocortisone Acetate cream	rx	1	1	SUPPLYING
Calcium Acetate capsule	rx	1	1	SUPPLYING
Decitabine injection, powder, lyophilized, for solution	rx	1	1	SUPPLYING
Lidocaine cream	otc	1	1	SUPPLYING

Showing 40 of 43 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.

At a glance

TypeLabeler
Labeler codes75834
Filing names1
Drugs (active)43
Drugs (all time)43
US registrations106
Packages215

Recent events

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

Oct 31, 2025
RECALLRecall (Class II): Nivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA Made in I…
Oct 31, 2025
RECALLRecall (Class II): Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA…
Oct 31, 2025
RECALLRecall (Class II): Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt. 15 oz (425g), Made in India, …
Sep 24, 2024
RECALLRecall (Class II): Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, I…

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.