NDC 21695-591

RAZADYNE

Galantamine Hydrobromide

RAZADYNE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Galantamine Hydrobromide.

Product ID21695-591_ea6968e3-6383-4ff1-8c81-e4a2fdfe749d
NDC21695-591
Product TypeHuman Prescription Drug
Proprietary NameRAZADYNE
Generic NameGalantamine Hydrobromide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2001-02-28
Marketing CategoryNDA / NDA
Application NumberNDA021169
Labeler NameRebel Distributors Corp
Substance NameGALANTAMINE HYDROBROMIDE
Active Ingredient Strength12 mg/1
Pharm ClassesCholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-591-30

30 TABLET, FILM COATED in 1 BOTTLE (21695-591-30)
Marketing Start Date2001-02-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-591-30 [21695059130]

RAZADYNE TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021169
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2001-02-28
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
GALANTAMINE HYDROBROMIDE12 mg/1

OpenFDA Data

SPL SET ID:e62efb5a-d2cc-4e11-9e61-10e65ef3d897
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 579148
  • 602734

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    21695-184RAZADYNEgalantamine hydrobromide
    21695-591RAZADYNEgalantamine hydrobromide
    50458-398RAZADYNERAZADYNE
    50458-389RAZADYNERAZADYNE
    50458-396RAZADYNERAZADYNE
    50458-387RAZADYNERAZADYNE
    50458-388RAZADYNERAZADYNE
    50458-397RAZADYNERAZADYNE
    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

    Trademark Results [RAZADYNE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    RAZADYNE
    RAZADYNE
    78567650 3118357 Live/Registered
    Johnson & Johnson
    2005-02-15
    RAZADYNE
    RAZADYNE
    76183268 not registered Dead/Abandoned
    JOHNSON & JOHNSON
    2000-12-20
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