NDC 0054-0092

Galantamine

Galantamine is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by West-ward Pharmaceuticals Corp.. The primary component is Galantamine Hydrobromide.

Product ID	0054-0092_37835c90-3b88-4b93-8645-4f9693cb0457
NDC	0054-0092
Product Type	Human Prescription Drug
Proprietary Name	Galantamine
Generic Name	Galantamine
Dosage Form	Tablet
Route of Administration	ORAL
Marketing Start Date	2016-06-01
Marketing Category	ANDA / ANDA
Application Number	ANDA077608
Labeler Name	West-Ward Pharmaceuticals Corp.
Substance Name	GALANTAMINE HYDROBROMIDE
Active Ingredient Strength	12 mg/1
Pharm Classes	Cholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC Exclude Flag	N
Listing Certified Through	2020-12-31

Packaging

NDC 0054-0092-21

60 TABLET in 1 BOTTLE (0054-0092-21)

Marketing Start Date	2016-08-05
NDC Exclude Flag	N
Sample Package?	N

NDC SPL Data Element Entries

NDC 0054-0092-21 [00054009221]

Galantamine TABLET

Marketing Category	ANDA
Application Number	ANDA077608
Product Type	HUMAN PRESCRIPTION DRUG
Billing Unit	EA
Marketing Start Date	2016-08-05
Marketing End Date	2021-01-09

Drug Details

Active Ingredients

Ingredient	Strength
GALANTAMINE HYDROBROMIDE	12 mg/1

OpenFDA Data

SPL SET ID:	d5b0e225-e94d-4324-afb2-b6e51c949dd0
Manufacturer	West-Ward Pharmaceuticals Corp.
UNII	MJ4PTD2VVW
RxNorm Concept Unique ID - RxCUI	579148 860901 310437 310436
UPC Code	0300540137496

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