Galantamine

Product NDC
0591-3497
11-digit product format
005913497
Labeler code
0591
Product ID
0591-3497_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
16 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
0591-3497-30EA - Each0591-349775f0b3d1-024f-413e-ae5f-eb2edc681a1212012-07-24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0591-3497-300059134973030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0591-3497-30) 2008-12-160000-00-00NoNoCurrent