Galantamine Hydrobromide

Product NDC
63629-2363
11-digit product format
636292363
Labeler code
63629
Product ID
63629-2363_f97c7222-1f0d-4108-ad70-8148eea0fec2
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
24 mg/1
Pharmacologic classes
Cholinesterase Inhibitor [EPC], Cholinesterase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Galantamine Hydrobromide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GALANTAMINE HYDROBROMIDE24 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMJ4PTD2VVW
Rxcui860707

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f780b87f-43f1-2d63-f0ea-2c214058238eProduct name220160831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-2363-1Galantamine Hydrobromide30 in 1 BOTTLECAPSULE, EXTENDED RELEASE30107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2363-1EA - Each63629-2363cc2ffad1-3732-4052-9d94-6f1501e68e2812021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2363GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]107Current NDC, Legacy NDC, 1 package rows20240814_3e7e2839-a834-4464-a82a-7554e10ad004.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860707galantamine HBr 24 MG 24HR Extended Release Oral CapsulePSN3e7e2839-a834-4464-a82a-7554e10ad004107
86070724 HR galantamine hydrobromide 24 MG Extended Release Oral CapsuleSCD3e7e2839-a834-4464-a82a-7554e10ad004107
860707galantamine hydrobromide 24 MG 24 HR Extended Release Oral CapsuleSY3e7e2839-a834-4464-a82a-7554e10ad004107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2363-16362923630130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-2363-1) 2011-02-090000-00-00NoNoCurrent