NDC Package 0781-3250-89 Glatopa

Glatiramer Acetate Injection, Solution Subcutaneous - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0781-3250-89
Package Description:
12 BLISTER PACK in 1 CARTON / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS (0781-3250-71)
Product Code:
Proprietary Name:
Glatopa
Non-Proprietary Name:
Glatiramer Acetate
Substance Name:
Glatiramer Acetate
Usage Information:
This medication is used to treat multiple sclerosis (MS). It is a protein that is thought to work by preventing your immune system from attacking the nerves in your brain and spinal cord. This effect can decrease the number of periods of disease worsening (relapses) and prevent or delay disability. It is not a cure for MS.
11-Digit NDC Billing Format:
00781325089
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 1111641 - glatiramer acetate 20 MG in 1 ML Prefilled Syringe
  • RxCUI: 1111641 - 1 ML glatiramer acetate 20 MG/ML Prefilled Syringe
  • RxCUI: 1111641 - glatiramer acetate 20 MG per 1 ML Prefilled Syringe
  • RxCUI: 1487361 - glatiramer acetate 40 MG/ML in 1 ML Prefilled Syringe
  • RxCUI: 1487361 - 1 ML glatiramer acetate 40 MG/ML Prefilled Syringe
  • Product Type:
    Human Prescription Drug
    Labeler Name:
    Sandoz Inc
    Dosage Form:
    Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
    Administration Route(s):
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Active Ingredient(s):
    Sample Package:
    No
    FDA Application Number:
    ANDA206921
    Marketing Category:
    ANDA - A product marketed under an approved Abbreviated New Drug Application.
    Start Marketing Date:
    02-12-2018
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0781-3250-89?

    The NDC Packaged Code 0781-3250-89 is assigned to a package of 12 blister pack in 1 carton / 1 syringe, glass in 1 blister pack / 1 ml in 1 syringe, glass (0781-3250-71) of Glatopa, a human prescription drug labeled by Sandoz Inc. The product's dosage form is injection, solution and is administered via subcutaneous form.

    Is NDC 0781-3250 included in the NDC Directory?

    Yes, Glatopa with product code 0781-3250 is active and included in the NDC Directory. The product was first marketed by Sandoz Inc on February 12, 2018 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0781-3250-89?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0781-3250-89?

    The 11-digit format is 00781325089. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20781-3250-895-4-200781-3250-89