NDC 43353-984

Galantamine hydrobromide

Galantamine Hydrobromide

Galantamine hydrobromide is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Galantamine Hydrobromide.

Product ID43353-984_ee9210aa-aedf-4658-bd12-0710ee2e54b8
NDC43353-984
Product TypeHuman Prescription Drug
Proprietary NameGalantamine hydrobromide
Generic NameGalantamine Hydrobromide
Dosage FormCapsule, Extended Release
Route of AdministrationORAL
Marketing Start Date2009-12-15
Marketing CategoryANDA / ANDA
Application NumberANDA079028
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameGALANTAMINE HYDROBROMIDE
Active Ingredient Strength16 mg/1
Pharm ClassesCholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43353-984-05

4200 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43353-984-05)
Marketing Start Date2015-11-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43353-984-05 [43353098405]

Galantamine hydrobromide CAPSULE, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA079028
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-11-15

Drug Details

Active Ingredients

IngredientStrength
GALANTAMINE HYDROBROMIDE16 mg/1

OpenFDA Data

SPL SET ID:9a04069a-02e2-4428-a73f-51e58b51af89
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 860695

    • Pharmacological Class

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

    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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.