FDA.reportPublic FDA data

Galantamine

Product NDC
57237-049
11-digit product format
572370049
Labeler code
57237
Product ID
57237-049_f59a93d6-9a01-40ad-a9ef-4eaacff23b79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Galantamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA090957
Marketing category
ANDA
Marketing start
2011-03-29
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, 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
57237-049-60Galantamine60 in 1 BOTTLETABLET, FILM COATED609

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-049-60EA - Each57237-049b0e7b223-b89c-4ece-9a9d-95f52f1844d312014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GALANTAMINE HYDROBROMIDEACTIVE INGREDIENTMJ4PTD2VVWGALANTAMINE TABLET, FILM COATED [CITRON PHARMA LLC]2
GALANTAMINEACTIVE MOIETY0D3Q044KCAGALANTAMINE TABLET, FILM COATED [CITRON PHARMA LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGALANTAMINE TABLET, FILM COATED [CITRON PHARMA LLC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GALANTAMINE TABLET, FILM COATED [CITRON PHARMA LLC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GALANTAMINE TABLET, FILM COATED [CITRON PHARMA LLC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGALANTAMINE TABLET, FILM COATED [CITRON PHARMA LLC]2
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4GALANTAMINE TABLET, FILM COATED [CITRON PHARMA LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GALANTAMINE TABLET, FILM COATED [CITRON PHARMA LLC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GALANTAMINE TABLET, FILM COATED [CITRON PHARMA LLC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GALANTAMINE TABLET, FILM COATED [CITRON PHARMA LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGALANTAMINE TABLET, FILM COATED [CITRON PHARMA LLC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UGALANTAMINE TABLET, FILM COATED [CITRON PHARMA LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGALANTAMINE TABLET, FILM COATED [CITRON PHARMA LLC]2
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
57237-049GALANTAMINE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.]9Current NDC, Legacy NDC, 1 package rows20240214_a0dc1a93-b7b8-4179-8ea7-ceecbe1ef243.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
579148galantamine HBr 12 MG Oral TabletPSNa0dc1a93-b7b8-4179-8ea7-ceecbe1ef2439
310436galantamine HBr 4 MG Oral TabletPSNa0dc1a93-b7b8-4179-8ea7-ceecbe1ef2439
310437galantamine HBr 8 MG Oral TabletPSNa0dc1a93-b7b8-4179-8ea7-ceecbe1ef2439
579148galantamine 12 MG Oral TabletSCDa0dc1a93-b7b8-4179-8ea7-ceecbe1ef2439
310436galantamine 4 MG Oral TabletSCDa0dc1a93-b7b8-4179-8ea7-ceecbe1ef2439
310437galantamine 8 MG Oral TabletSCDa0dc1a93-b7b8-4179-8ea7-ceecbe1ef2439
579148galantamine 12 MG (as galantamine hydrobromide 15.379 MG) Oral TabletSYa0dc1a93-b7b8-4179-8ea7-ceecbe1ef2439
310436galantamine 4 MG (as galantamine hydrobromide 5.126 MG) Oral TabletSYa0dc1a93-b7b8-4179-8ea7-ceecbe1ef2439
310437galantamine 8 MG (as galantamine hydrobromide 10.253 MG) Oral TabletSYa0dc1a93-b7b8-4179-8ea7-ceecbe1ef2439
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57237-049-605723700496060 TABLET, FILM COATED in 1 BOTTLE (57237-049-60) 2011-03-290000-00-00NoNoCurrent