FDA.reportPublic FDA data

Galantamine

Product NDC
65862-458
11-digit product format
658620458
Labeler code
65862
Product ID
65862-458_a5420811-7ce9-4ea6-8d93-6422f016b0d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Galantamine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
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
65862-458-19Galantamine10000 in 1 BOTTLETABLET, FILM COATED1000014
65862-458-60Galantamine60 in 1 BOTTLETABLET, FILM COATED6014
65862-458-99Galantamine1000 in 1 BOTTLETABLET, FILM COATED100014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-458-60EA - Each65862-458d6d73fea-3199-4de4-935d-66482bdf86ab12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GALANTAMINE HYDROBROMIDEACTIVE INGREDIENTMJ4PTD2VVWGALANTAMINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
GALANTAMINEACTIVE MOIETY0D3Q044KCAGALANTAMINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UGALANTAMINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8GALANTAMINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GALANTAMINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGALANTAMINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4GALANTAMINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30GALANTAMINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GALANTAMINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4GALANTAMINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJGALANTAMINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
TALCINACTIVE INGREDIENT7SEV7J4R1UGALANTAMINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGALANTAMINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-458GALANTAMINE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]14Current NDC, Legacy NDC, 3 package rows20240210_4e05d1da-0eb8-4fe0-8259-f1ebb170e0dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
579148galantamine HBr 12 MG Oral TabletPSN4e05d1da-0eb8-4fe0-8259-f1ebb170e0dc14
310436galantamine HBr 4 MG Oral TabletPSN4e05d1da-0eb8-4fe0-8259-f1ebb170e0dc14
310437galantamine HBr 8 MG Oral TabletPSN4e05d1da-0eb8-4fe0-8259-f1ebb170e0dc14
579148galantamine 12 MG Oral TabletSCD4e05d1da-0eb8-4fe0-8259-f1ebb170e0dc14
310436galantamine 4 MG Oral TabletSCD4e05d1da-0eb8-4fe0-8259-f1ebb170e0dc14
310437galantamine 8 MG Oral TabletSCD4e05d1da-0eb8-4fe0-8259-f1ebb170e0dc14
579148galantamine 12 MG (as galantamine hydrobromide 15.379 MG) Oral TabletSY4e05d1da-0eb8-4fe0-8259-f1ebb170e0dc14
310436galantamine 4 MG (as galantamine hydrobromide 5.126 MG) Oral TabletSY4e05d1da-0eb8-4fe0-8259-f1ebb170e0dc14
310437galantamine 8 MG (as galantamine hydrobromide 10.253 MG) Oral TabletSY4e05d1da-0eb8-4fe0-8259-f1ebb170e0dc14
310436galantamine HBr 4 MG Oral TabletPSN261889d3-41c8-4655-98f7-41317778e7a11
310436galantamine 4 MG Oral TabletSCD261889d3-41c8-4655-98f7-41317778e7a11
310436galantamine 4 MG (as galantamine hydrobromide 5.126 MG) Oral TabletSY261889d3-41c8-4655-98f7-41317778e7a11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-458-196586204581910000 TABLET, FILM COATED in 1 BOTTLE (65862-458-19) 2011-03-290000-00-00NoNoCurrent
65862-458-296586204582920000 TABLET, FILM COATED in 1 BAG (65862-458-29)29-MAR-11Current
65862-458-606586204586060 TABLET, FILM COATED in 1 BOTTLE (65862-458-60) 2011-03-290000-00-00NoNoCurrent
65862-458-99658620458991000 TABLET, FILM COATED in 1 BOTTLE (65862-458-99) 2011-03-290000-00-00NoNoCurrent