FDA.reportPublic FDA data

Galantamine

Product NDC
24979-723
11-digit product format
249790723
Labeler code
24979
Product ID
24979-723_4685d63a-b3bc-416d-e063-6294a90afce3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
galantamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Upsher-Smith Laboratories, LLC
Application
ANDA077604
Marketing category
ANDA
Marketing start
2024-03-06
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GALANTAMINE HYDROBROMIDE8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMJ4PTD2VVW
Rxcui310436, 310437, 579148

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
24979-723-04Galantamine60 in 1 BOTTLETABLET, FILM COATED607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24979-723-04EA - Each24979-723df52fe33-0335-48a7-980e-8ef5cb012f0a12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24979-723GALANTAMINE TABLET, FILM COATED [UPSHER-SMITH LABORATORIES, LLC]4Current NDC, 1 package rows20241208_10497273-d907-0514-e063-6294a90a1362.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
579148galantamine HBr 12 MG Oral TabletPSN18fd8860-d9ab-1b17-e063-6294a90aad9a5
310436galantamine HBr 4 MG Oral TabletPSN18fd8860-d9ab-1b17-e063-6294a90aad9a5
310437galantamine HBr 8 MG Oral TabletPSN18fd8860-d9ab-1b17-e063-6294a90aad9a5
579148galantamine 12 MG Oral TabletSCD18fd8860-d9ab-1b17-e063-6294a90aad9a5
310436galantamine 4 MG Oral TabletSCD18fd8860-d9ab-1b17-e063-6294a90aad9a5
310437galantamine 8 MG Oral TabletSCD18fd8860-d9ab-1b17-e063-6294a90aad9a5
579148galantamine 12 MG (as galantamine hydrobromide 15.379 MG) Oral TabletSY18fd8860-d9ab-1b17-e063-6294a90aad9a5
310436galantamine 4 MG (as galantamine hydrobromide 5.126 MG) Oral TabletSY18fd8860-d9ab-1b17-e063-6294a90aad9a5
310437galantamine 8 MG (as galantamine hydrobromide 10.253 MG) Oral TabletSY18fd8860-d9ab-1b17-e063-6294a90aad9a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
24979-723-042497907230460 TABLET, FILM COATED in 1 BOTTLE (24979-723-04) 2024-03-06NoNoCurrent