NDC 0378-2722

Galantamine

Galantamine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Galantamine Hydrobromide.

Product ID	0378-2722_8ef24417-c577-412c-80fe-06a747cbd70f
NDC	0378-2722
Product Type	Human Prescription Drug
Proprietary Name	Galantamine
Generic Name	Galantamine
Dosage Form	Tablet, Film Coated
Route of Administration	ORAL
Marketing Start Date	2008-08-29
Marketing End Date	2019-12-31
Marketing Category	ANDA / ANDA
Application Number	ANDA077590
Labeler Name	Mylan Pharmaceuticals Inc.
Substance Name	GALANTAMINE HYDROBROMIDE
Active Ingredient Strength	8 mg/1
Pharm Classes	Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC Exclude Flag	N

Packaging

NDC 0378-2722-91

60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2722-91)

Marketing Start Date	2008-08-29
NDC Exclude Flag	N
Sample Package?	N

NDC SPL Data Element Entries

NDC 0378-2722-05 [00378272205]

Galantamine TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA077590
Product Type	HUMAN PRESCRIPTION DRUG
Marketing Start Date	2008-08-29
Marketing End Date	2016-06-13

NDC 0378-2722-91 [00378272291]

Galantamine TABLET, FILM COATED

Marketing Category	ANDA
Application Number	ANDA077590
Product Type	HUMAN PRESCRIPTION DRUG
Billing Unit	EA
Marketing Start Date	2008-08-29
Marketing End Date	2019-12-31

Drug Details

Pharmacological Class

Cholinesterase Inhibitor [EPC]
Cholinesterase Inhibitors [MoA]

NDC Crossover Matching brand name "Galantamine" or generic name "Galantamine"

NDC	Brand Name	Generic Name
0054-0090	Galantamine	Galantamine
0054-0091	Galantamine	Galantamine
0054-0092	Galantamine	Galantamine
0378-2721	Galantamine	galantamine
0378-2722	Galantamine	galantamine
0378-2723	Galantamine	galantamine
0591-3496	Galantamine	Galantamine
0591-3497	Galantamine	Galantamine
0591-3498	Galantamine	Galantamine
0615-7541	Galantamine	Galantamine
0615-7542	Galantamine	Galantamine
0615-7543	Galantamine	Galantamine
0904-7104	Galantamine	galantamine
51079-852	Galantamine	galantamine
51079-853	Galantamine	galantamine
57237-049	Galantamine	Galantamine
57237-050	Galantamine	Galantamine
68084-729	Galantamine	Galantamine
68382-177	galantamine	galantamine
68382-178	galantamine	galantamine
68382-179	galantamine	galantamine
70436-005	Galantamine	Galantamine
70436-004	Galantamine	Galantamine
70436-006	Galantamine	Galantamine
57237-051	Galantamine	Galantamine
60505-2542	Galantamine	Galantamine
60505-2543	Galantamine	Galantamine
60505-2544	Galantamine	Galantamine
63739-708	Galantamine	Galantamine
63739-999	Galantamine	Galantamine
65862-458	Galantamine	Galantamine
65862-745	Galantamine	Galantamine
65841-755	Galantamine	Galantamine
65862-459	Galantamine	Galantamine
65862-460	Galantamine	Galantamine
65862-746	Galantamine	Galantamine
65841-756	Galantamine	Galantamine
65841-757	Galantamine	Galantamine
65862-744	Galantamine	Galantamine