NDC 0054-0137

Galantamine Hydrobromide

Galantamine Hydrobromide

Galantamine Hydrobromide is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by West-ward Pharmaceuticals Corp.. The primary component is Galantamine Hydrobromide.

Product ID0054-0137_37835c90-3b88-4b93-8645-4f9693cb0457
NDC0054-0137
Product TypeHuman Prescription Drug
Proprietary NameGalantamine Hydrobromide
Generic NameGalantamine Hydrobromide
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2009-08-14
Marketing CategoryANDA / ANDA
Application NumberANDA078185
Labeler NameWest-Ward Pharmaceuticals Corp.
Substance NameGALANTAMINE HYDROBROMIDE
Active Ingredient Strength4 mg/mL
Pharm ClassesCholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0054-0137-49

100 mL in 1 BOTTLE (0054-0137-49)
Marketing Start Date2009-08-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0054-0137-49 [00054013749]

Galantamine Hydrobromide SOLUTION
Marketing CategoryANDA
Application NumberANDA078185
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-08-14

Drug Details

Active Ingredients

IngredientStrength
GALANTAMINE HYDROBROMIDE4 mg/mL

OpenFDA Data

SPL SET ID:d5b0e225-e94d-4324-afb2-b6e51c949dd0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 579148
  • 860901
  • 310437
  • 310436
    • UPC Code
  • 0300540137496

    • Pharmacological Class

    • 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
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