Galantamine

Product NDC: 0591-3498
11-digit product format: 005913498
Labeler code: 0591
Product ID: 0591-3498_f5a193b9-78b1-4bfe-97b1-a98969f0f303
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Galantamine
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA079028
Marketing category: ANDA
Marketing start: 2008-12-15
Marketing end: 0000-00-00
Substance: GALANTAMINE HYDROBROMIDE
Active strength: 24 mg/1
Pharmacologic classes: Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0591-3498-30	EA - Each	0591-3498	1d5e47e1-ab8f-4928-b5d1-fd357d965e12	1	2012-07-24

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
MJ4PTD2VVW	GALANTAMINE HYDROBROMIDE	1953-04-4	GALANTAMINE HYDROBROMIDE
0D3Q044KCA	GALANTAMINE	357-70-0	Galantamine

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0591-3498-30	00591349830	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0591-3498-30)	2008-12-16	0000-00-00	No	No	Current