Galantamine Hydrobromide

Product NDC
63629-2364
11-digit product format
636292364
Labeler code
63629
Product ID
63629-2364_241d4ec3-7582-4846-8d78-6b9840053c98
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
8 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 HYDROBROMIDE8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMJ4PTD2VVW
Rxcui860715

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
63629-2364-1Galantamine Hydrobromide30 in 1 BOTTLECAPSULE, EXTENDED RELEASE30106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2364-1EA - Each63629-23644cf33bf8-fd5c-4374-b89d-d2548ff3066212021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2364GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 1 package rows20240814_db5b6c1e-449b-413f-b0cc-ca2133aa4986.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860715galantamine HBr 8 MG 24HR Extended Release Oral CapsulePSNdb5b6c1e-449b-413f-b0cc-ca2133aa4986106
86071524 HR galantamine hydrobromide 8 MG Extended Release Oral CapsuleSCDdb5b6c1e-449b-413f-b0cc-ca2133aa4986106
860715galantamine hydrobromide 8 MG 24 HR Extended Release Oral CapsuleSYdb5b6c1e-449b-413f-b0cc-ca2133aa4986106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-2364-16362923640130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-2364-1) 2011-02-090000-00-00NoNoCurrent