FDA.reportPublic FDA data

Galantamine

Product NDC
65862-746
11-digit product format
658620746
Labeler code
65862
Product ID
65862-746_5b352114-093a-450c-81d1-4914dac5e2e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Galantamine
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA204895
Marketing category
ANDA
Marketing start
2016-08-05
Substance
GALANTAMINE HYDROBROMIDE
Active strength
24 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 HYDROBROMIDE24 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMJ4PTD2VVW
Rxcui860695, 860707, 860715

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
65862-746-01Galantamine100 in 1 BOTTLECAPSULE, EXTENDED RELEASE10011
65862-746-05Galantamine500 in 1 BOTTLECAPSULE, EXTENDED RELEASE50011
65862-746-30Galantamine30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3011
65862-746-90Galantamine90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9011
65862-746-99Galantamine1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE100011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-746-30EA - Each65862-746be217eeb-be45-43df-917c-f7ba4edf206a12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-746GALANTAMINE CAPSULE, EXTENDED RELEASE [AUROBINDO PHARMA LIMITED]11Current NDC, Legacy NDC, 5 package rows20240201_d0b75970-8d3d-408b-9e17-9cbad0f776b1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860695galantamine HBr 16 MG 24HR Extended Release Oral CapsulePSNd0b75970-8d3d-408b-9e17-9cbad0f776b111
860707galantamine HBr 24 MG 24HR Extended Release Oral CapsulePSNd0b75970-8d3d-408b-9e17-9cbad0f776b111
860715galantamine HBr 8 MG 24HR Extended Release Oral CapsulePSNd0b75970-8d3d-408b-9e17-9cbad0f776b111
86069524 HR galantamine hydrobromide 16 MG Extended Release Oral CapsuleSCDd0b75970-8d3d-408b-9e17-9cbad0f776b111
86070724 HR galantamine hydrobromide 24 MG Extended Release Oral CapsuleSCDd0b75970-8d3d-408b-9e17-9cbad0f776b111
86071524 HR galantamine hydrobromide 8 MG Extended Release Oral CapsuleSCDd0b75970-8d3d-408b-9e17-9cbad0f776b111
860695galantamine hydrobromide 16 MG 24 HR Extended Release Oral CapsuleSYd0b75970-8d3d-408b-9e17-9cbad0f776b111
860707galantamine hydrobromide 24 MG 24 HR Extended Release Oral CapsuleSYd0b75970-8d3d-408b-9e17-9cbad0f776b111
860715galantamine hydrobromide 8 MG 24 HR Extended Release Oral CapsuleSYd0b75970-8d3d-408b-9e17-9cbad0f776b111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-746-0165862074601100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-746-01) 2016-08-050000-00-00NoNoCurrent
65862-746-0565862074605500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-746-05) 2016-08-050000-00-00NoNoCurrent
65862-746-306586207463030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-746-30) 2016-08-050000-00-00NoNoCurrent
65862-746-906586207469090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-746-90) 2016-08-050000-00-00NoNoCurrent
65862-746-99658620746991000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65862-746-99) 2016-08-050000-00-00NoNoCurrent