NDC 47335-835

Galantamine Hydrobromide

Galantamine Hydrobromide

Galantamine Hydrobromide is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Galantamine Hydrobromide.

Product ID47335-835_42b1fd73-3e48-40d2-ade4-8f5a082c197e
NDC47335-835
Product TypeHuman Prescription Drug
Proprietary NameGalantamine Hydrobromide
Generic NameGalantamine Hydrobromide
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2011-02-09
Marketing CategoryANDA / ANDA
Application NumberANDA090178
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameGALANTAMINE HYDROBROMIDE
Active Ingredient Strength8 mg/1
Pharm ClassesCholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 47335-835-08

100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (47335-835-08)
Marketing Start Date2011-02-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 47335-835-18 [47335083518]

Galantamine Hydrobromide CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA090178
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-02-09

NDC 47335-835-83 [47335083583]

Galantamine Hydrobromide CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA090178
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-02-09

NDC 47335-835-08 [47335083508]

Galantamine Hydrobromide CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA090178
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-02-09

NDC 47335-835-88 [47335083588]

Galantamine Hydrobromide CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA090178
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-02-09

Drug Details

Active Ingredients

IngredientStrength
GALANTAMINE HYDROBROMIDE8 mg/1

OpenFDA Data

SPL SET ID:d1697161-ebe8-42b0-83e7-c9de4412546c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 860695
  • 860707
  • 860715
    • UPC Code
  • 0347335835830
  • 0347335836837
  • 0347335837834

    • Pharmacological Class

    • Cholinesterase Inhibitor [EPC]
    • Cholinesterase Inhibitors [MoA]
    • Cholinesterase Inhibitor [EPC]
    • Cholinesterase Inhibitors [MoA]

    Medicade Reported Pricing

    47335083583 GALANTAMINE ER 8 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Galantamine Hydrobromide" or generic name "Galantamine Hydrobromide"

    NDCBrand NameGeneric Name
    0054-0137Galantamine HydrobromideGalantamine Hydrobromide
    10147-0881galantamine hydrobromidegalantamine hydrobromide
    10147-0882galantamine hydrobromidegalantamine hydrobromide
    10147-0883galantamine hydrobromidegalantamine hydrobromide
    10147-0891galantamine hydrobromidegalantamine hydrobromide
    10147-0892galantamine hydrobromidegalantamine hydrobromide
    10147-0893galantamine hydrobromidegalantamine hydrobromide
    43353-984Galantamine hydrobromideGalantamine hydrobromide
    47335-835Galantamine HydrobromideGalantamine Hydrobromide
    47335-836Galantamine HydrobromideGalantamine Hydrobromide
    47335-837Galantamine HydrobromideGalantamine Hydrobromide
    51990-112Galantamine HydrobromideGalantamine Hydrobromide
    51990-111Galantamine HydrobromideGalantamine Hydrobromide
    51990-113Galantamine HydrobromideGalantamine Hydrobromide
    21695-184RAZADYNEgalantamine hydrobromide
    21695-591RAZADYNEgalantamine hydrobromide
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.