Novitium Pharma LLC

Novitium Pharma LLC lists 17 drug products in the FDA National Drug Code directory.

Products

NDC	Product	Strength	Type
70954-455	Bisoprolol Fumarate Tablet	Bisoprolol Fumarate 5 mg/1	Rx
70954-456	Bisoprolol Fumarate Tablet	Bisoprolol Fumarate 10 mg/1	Rx
70954-085	Chlorzoxazone Tablet	Chlorzoxazone 500 mg/1	Rx
70954-036	Clotrimazole Solution	Clotrimazole 10 mg/mL	Rx
70954-261	Dicyclomine Hydrochloride Solution	Dicyclomine Hydrochloride 10 mg/5mL	Rx
70954-481	Estazolam Tablet	Estazolam 2 mg/1	Rx
70954-480	Estazolam Tablet	Estazolam 1 mg/1	Rx
70954-051	Felbamate Suspension	Felbamate 600 mg/5mL	Rx
70954-252	Fludrocortisone Acetate Tablet	Fludrocortisone Acetate .1 mg/1	Rx
70954-518	Lidocaine Hydrochloride Solution	Lidocaine Hydrochloride 40 mg/mL	Rx
70954-365	Phenoxybenzamine Hydrochloride Capsule	Phenoxybenzamine Hydrochloride 10 mg/1	Rx
70954-148	Pyridostigmine Solution	Pyridostigmine Bromide 60 mg/5mL	Rx
70954-504	Selegiline Hydrochloride Capsule	Selegiline Hydrochloride 5 mg/1	Rx
70954-538	Tranylcypromine Tablet	Tranylcypromine Sulfate 10 mg/1	Rx
70954-212	Trihexyphenidyl Hydrochloride Tablet	Trihexyphenidyl Hydrochloride 2 mg/1	Rx
70954-211	Trihexyphenidyl Hydrochloride Tablet	Trihexyphenidyl Hydrochloride 5 mg/1	Rx
70954-541	Trimethoprim Tablet	Trimethoprim 100 mg/1	Rx

D-0443-2024 Apr 24, 2024 · Class III
Failed Impurities/Degradation Specifications
D-0389-2024 Mar 27, 2024 · Class III
Cross Contamination with Other Products:(mycophenolate mofetil).
D-0313-2020 Nov 20, 2019 · Class II
CGMP Deviations: Presence of NDMA impurity detected in product.
D-0312-2020 Nov 20, 2019 · Class II
CGMP Deviations: Presence of NDMA impurity detected in product.
D-0311-2020 Nov 20, 2019 · Class II
CGMP Deviations: Presence of NDMA impurity detected in product.
D-0310-2020 Nov 20, 2019 · Class II
CGMP Deviations: Presence of NDMA impurity detected in product.