FDA.reportPublic FDA data

Galantamine

Product NDC
68084-729
11-digit product format
680840729
Labeler code
68084
Product ID
68084-729_2864c9b5-d581-daf1-e063-6394a90a2923
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Galantamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
American Health Packaging
Application
ANDA090957
Marketing category
ANDA
Marketing start
2014-07-03
Substance
GALANTAMINE HYDROBROMIDE
Active strength
4 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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GALANTAMINE HYDROBROMIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMJ4PTD2VVW
Rxcui310436

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
68084-729-11Galantamine1 in 1 BLISTER PACKTABLET, FILM COATED18
68084-729-21Galantamine30 in 1 BOX, UNIT-DOSETABLET, FILM COATED308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-729-11EA - Each68084-7295fbbc4d3-4b9d-42d2-af67-cfc805c1719f12014-08-01
68084-729-21EA - Each68084-729d5eeb946-e9b6-4158-ab51-9d58f0650b2712014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GALANTAMINE HYDROBROMIDEACTIVE INGREDIENTMJ4PTD2VVWGALANTAMINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
GALANTAMINEACTIVE MOIETY0D3Q044KCAGALANTAMINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGALANTAMINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGALANTAMINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4GALANTAMINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GALANTAMINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GALANTAMINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GALANTAMINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGALANTAMINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
TALCINACTIVE INGREDIENT7SEV7J4R1UGALANTAMINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGALANTAMINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-729GALANTAMINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]8Current NDC, Legacy NDC, 2 package rows20241208_e80ec152-3616-4a13-9266-715550a8c398.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310436galantamine HBr 4 MG Oral TabletPSNe80ec152-3616-4a13-9266-715550a8c3988
310436galantamine 4 MG Oral TabletSCDe80ec152-3616-4a13-9266-715550a8c3988
310436galantamine 4 MG (as galantamine hydrobromide 5.126 MG) Oral TabletSYe80ec152-3616-4a13-9266-715550a8c3988

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-729-11680840729111 in 1 BLISTER PACKHistorical
68084-729-216808407292130 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-729-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-729-11) 30 blister pack2014-07-030000-00-00NoNoCurrent