Galantamine Hydrobromide

Product NDC
72162-1446
11-digit product format
721621446
Labeler code
72162
Product ID
72162-1446_c44108aa-bf20-4d45-b36f-d117320a675b
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
72162-1446-3Galantamine Hydrobromide30 in 1 BOTTLECAPSULE, EXTENDED RELEASE30101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1446-3EA - Each72162-1446e0da70a2-276e-4905-a278-3a33adc5ffb212023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1446GALANTAMINE HYDROBROMIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]101Current NDC, 1 package rows20240413_c44108aa-bf20-4d45-b36f-d117320a675b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860715galantamine HBr 8 MG 24HR Extended Release Oral CapsulePSNc44108aa-bf20-4d45-b36f-d117320a675b101
86071524 HR galantamine hydrobromide 8 MG Extended Release Oral CapsuleSCDc44108aa-bf20-4d45-b36f-d117320a675b101
860715galantamine hydrobromide 8 MG 24 HR Extended Release Oral CapsuleSYc44108aa-bf20-4d45-b36f-d117320a675b101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-1446-37216214460330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-1446-3) 2011-02-09NoNoHistorical