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  5. NDC Package Code: 47335-991-02 Glatiramer Acetate

NDC Package 47335-991-02 Glatiramer Acetate

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

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

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:
47335-991-02
Package Description:
12 BLISTER PACK in 1 CARTON / 1 SYRINGE in 1 BLISTER PACK / 1 mL in 1 SYRINGE
Product Code:
47335-991
Proprietary Name:
Glatiramer Acetate
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:
47335099102
Product Type:
Human Prescription Drug
Labeler Name:
Sun Pharmaceutical Industries, 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):
GLATIRAMER ACETATE 40 mg/mL
Sample Package:
No
FDA Application Number:
ANDA206873
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
08-15-2025
Listing Expiration Date:
12-31-2026
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 47335-991-02?

The NDC Packaged Code 47335-991-02 is assigned to a package of 12 blister pack in 1 carton / 1 syringe in 1 blister pack / 1 ml in 1 syringe of Glatiramer Acetate, a human prescription drug labeled by Sun Pharmaceutical Industries, Inc.. The product's dosage form is injection, solution and is administered via subcutaneous form.

Is NDC 47335-991 included in the NDC Directory?

Yes, Glatiramer Acetate with product code 47335-991 is active and included in the NDC Directory. The product was first marketed by Sun Pharmaceutical Industries, Inc. on August 15, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 47335-991-02?

The 11-digit format is 47335099102. 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 5-3-2 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
5-3-247335-991-025-4-247335-0991-02