NDC 0781-3250

Glatopa

Glatiramer Acetate

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

Product ID0781-3250_027279ad-06a6-4ccf-9c8a-c506fb3f1226
NDC0781-3250
Product TypeHuman Prescription Drug
Proprietary NameGlatopa
Generic NameGlatiramer Acetate
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2018-02-12
Marketing CategoryANDA / ANDA
Application NumberANDA206921
Labeler NameSandoz Inc
Substance NameGLATIRAMER ACETATE
Active Ingredient Strength40 mg/mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0781-3250-89

12 BLISTER PACK in 1 CARTON (0781-3250-89) > 1 SYRINGE, GLASS in 1 BLISTER PACK > 1 mL in 1 SYRINGE, GLASS (0781-3250-71)
Marketing Start Date2018-02-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-3250-89 [00781325089]

Glatopa INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA206921
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-02-12

NDC 0781-3250-71 [00781325071]

Glatopa INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA206921
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-02-12

Drug Details

Active Ingredients

IngredientStrength
GLATIRAMER ACETATE40 mg/mL

OpenFDA Data

SPL SET ID:5f01e40a-b6f6-40fb-b37c-3d06f1428e86
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1111641
  • 2000007
  • 1487361
  • 1654630
  • NDC Crossover Matching brand name "Glatopa" or generic name "Glatiramer Acetate"

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

    Trademark Results [Glatopa]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    GLATOPA
    GLATOPA
    86390315 4819540 Live/Registered
    Novartis AG
    2014-09-10
    GLATOPA
    GLATOPA
    85271930 not registered Dead/Abandoned
    Novartis AG
    2011-03-21

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