NDC 68546-317

Copaxone

Glatiramer Acetate

Copaxone is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Teva Neuroscience, Inc.. The primary component is Glatiramer Acetate.

Product ID68546-317_04f9ea25-0d45-4e44-8ed8-dc61db4f5466
NDC68546-317
Product TypeHuman Prescription Drug
Proprietary NameCopaxone
Generic NameGlatiramer Acetate
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2008-04-28
Marketing CategoryNDA / NDA
Application NumberNDA020622
Labeler NameTeva Neuroscience, Inc.
Substance NameGLATIRAMER ACETATE
Active Ingredient Strength20 mg/mL
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 68546-317-30

30 BLISTER PACK in 1 CARTON (68546-317-30) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS
Marketing Start Date2008-04-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68546-317-00 [68546031700]

Copaxone INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020622
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-06-04
Marketing End Date2015-02-28

NDC 68546-317-30 [68546031730]

Copaxone INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020622
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2008-04-28

Drug Details

Active Ingredients

IngredientStrength
GLATIRAMER ACETATE20 mg/mL

OpenFDA Data

SPL SET ID:aa88f583-4f5f-433b-80b4-1f4c9fb28357
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1111641
  • 1487363
  • 1111642
  • 1487361
  • Medicade Reported Pricing

    68546031730 COPAXONE 20 MG/ML SYRINGE

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "Copaxone" or generic name "Glatiramer Acetate"

    NDCBrand NameGeneric Name
    68546-317CopaxoneGlatiramer Acetate
    68546-325CopaxoneGlatiramer Acetate
    0378-6960Glatiramer Acetateglatiramer acetate
    0781-3234GlatopaGlatiramer Acetate
    0781-3250GlatopaGlatiramer Acetate
    63629-8815GlatopaGlatiramer Acetate
    63629-8816GlatopaGlatiramer Acetate

    Trademark Results [Copaxone]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    COPAXONE
    COPAXONE
    74348964 1816603 Live/Registered
    TEVA PHARMACEUTICAL INDUSTRIES LTD.
    1993-01-15

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