Labeler · US market

Novitium Pharma LLC

Novitium Pharma LLC is a US drug labeler with US FDA registrations covering 14 drug concepts (14 currently active) across 26 packages. It is currently the only active US supplier of 2 drugs.

ACTIVE — US

openFDA · updated weekly

Labeler codes70954

Active drugs14

Registrations17 active / 17

Packages26

Sole supplier of2 drugs

Portfolio14 drugs · US

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

Drug	Type	NDCs	Packages	Status
Trihexyphenidyl Hydrochloride tablet	rx	2	4	SUPPLYING
Bisoprolol Fumarate tablet	rx	2	4	SUPPLYING
Fludrocortisone Acetate tablet	rx	1	3	SUPPLYING
Felbamate suspension	rx	1	2	SUPPLYING
Chlorzoxazone tablet	rx	1	2	SUPPLYING
Estazolam tablet	rx	2	2	SUPPLYING
Selegiline Hydrochloride capsule	rx	1	2	SUPPLYING
Phenoxybenzamine Hydrochloride capsule	rx	1	1	SUPPLYING
Tranylcypromine tablet	rx	1	1	SUPPLYING
Trimethoprim tablet	rx	1	1	SUPPLYING
Clotrimazole Topical solution	rx	1	1	SUPPLYING
Pyridostigmine Bromide Oral solution	rx	1	1	SUPPLYING
Dicyclomine Hydrochloride solution	rx	1	1	SUPPLYING
Lidocaine Hydrochloride solution	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.

At a glance

TypeLabeler
Labeler codes70954
Filing names1
Drugs (active)14
Drugs (all time)14
US registrations17
Packages26

Recent events

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

Mar 25, 2024
RECALLRecall (Class III): Digoxin Tablets, USP 62.5 mcg (0.0625 mg), 100-count bottles, Rx Only, Manufactured by: Novitium Pharma LLC, 70 Lake Dr…
Mar 4, 2024
RECALLRecall (Class III): Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by: Novitium Pharma LLC., 70 Lake Dri…
Oct 25, 2019
RECALLRecall (Class II): Novitium Pharma Ranitidine Capsules 300 mg 100 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, Eas…
Oct 25, 2019
RECALLRecall (Class II): Novitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East…
Oct 25, 2019
RECALLRecall (Class II): Novitium Pharma Ranitidine Capsules 150 mg 500 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, Eas…
Oct 25, 2019
RECALLRecall (Class II): Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East…

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.