NDC 50458-397

RAZADYNE

Galantamine Hydrobromide

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

Product ID50458-397_0ddefa6e-7ea6-11e8-9f45-a7959d46d017
NDC50458-397
Product TypeHuman Prescription Drug
Proprietary NameRAZADYNE
Generic NameGalantamine Hydrobromide
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2001-03-01
Marketing CategoryNDA / NDA
Application NumberNDA021169
Labeler NameJanssen Pharmaceuticals, Inc.
Substance NameGALANTAMINE HYDROBROMIDE
Active Ingredient Strength8 mg/1
Pharm ClassesCholinesterase Inhibitor [EPC],Cholinesterase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 50458-397-60

60 TABLET, FILM COATED in 1 BOTTLE (50458-397-60)
Marketing Start Date2001-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50458-397-60 [50458039760]

RAZADYNE TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021169
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2001-03-01
Marketing End Date2020-03-31

Drug Details

Active Ingredients

IngredientStrength
GALANTAMINE HYDROBROMIDE8 mg/1

OpenFDA Data

SPL SET ID:ec9b5a9c-8caf-4f9b-8c1b-209b2de556dc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 860707
  • 860715
  • 860717
  • 860695
  • 860901
  • 860697
  • 602734
  • 310436
  • 602736
  • 602737
  • 579148
  • 310437
  • 860903
  • 860709
    • UPC Code
  • 0350458388305
  • 0350458387308
  • 0350458397604

    • 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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