Galantamine Hydrobromide

Product NDC
63629-2365
11-digit product format
636292365
Labeler code
63629
Product ID
63629-2365_1f5f7a01-fa97-4448-b3a2-755e8271cbeb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Galantamine Hydrobromide
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090178
Marketing category
ANDA
Marketing start
2011-02-09
Substance
GALANTAMINE HYDROBROMIDE
Active strength
16 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
MJ4PTD2VVWGALANTAMINE HYDROBROMIDE1953-04-4GALANTAMINE HYDROBROMIDE

Packages

Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
63629-2365-16362923650130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-2365-1) 2011-02-09NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Galantamine HydrobromideBryant Ranch Prepack2024-08-12HUMAN PRESCRIPTION DRUG LABEL105