Galantamine

Product NDC
0591-3496
11-digit product format
005913496
Labeler code
0591
Product ID
0591-3496_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
8 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 NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-3496-30EA - Each0591-3496436247a8-370f-47da-8875-a6886ed5d10912012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-3496-300059134963030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0591-3496-30) 2008-12-160000-00-00NoNoCurrent