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NDC 00378-6961-12 Glatiramer Acetate 40 mg/mL Details
Glatiramer Acetate 40 mg/mL
Glatiramer Acetate is a SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is GLATIRAMER ACETATE.
MedlinePlus Drug Summary
Glatiramer injection is used to treat adults with various forms of multiple sclerosis (MS; a disease in which the nerves do not function properly and people may experience weakness, numbness, loss of muscle coordination, and problems with vision, speech, and bladder control) including: clinically isolated syndrome (CIS; nerve symptom episodes that last at least 24 hours), relapsing-remitting forms (course of disease where symptoms flare up from time to time), or secondary progressive forms (course of disease where relapses occur more often). Glatiramer is in a class of medications called immunomodulators. It works by stopping the body from damaging its own nerve cells (myelin).
Related Packages: 00378-6961-12Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Glatiramer Injection
Product Information
| NDC | 00378-6961 |
|---|---|
| Product ID | 0378-6961_8ec038d7-e115-4532-b2f1-0c6fe8608ab9 |
| Associated GPIs | 6240003010E540 |
| GCN Sequence Number | 071942 |
| GCN Sequence Number Description | glatiramer acetate SYRINGE 40 MG/ML SUBCUT |
| HIC3 | H0E |
| HIC3 Description | AGENTS TO TREAT MULTIPLE SCLEROSIS |
| GCN | 35983 |
| HICL Sequence Number | 012810 |
| HICL Sequence Number Description | GLATIRAMER ACETATE |
| Brand/Generic | Generic |
| Proprietary Name | Glatiramer Acetate |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Glatiramer |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | SUBCUTANEOUS |
| Active Ingredient Strength | 40 |
| Active Ingredient Units | mg/mL |
| Substance Name | GLATIRAMER ACETATE |
| Labeler Name | Mylan Pharmaceuticals Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA206936 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00378-6961-12 (00378696112)
| NDC Package Code | 0378-6961-12 |
|---|---|
| Billing NDC | 00378696112 |
| Package | 12 BLISTER PACK in 1 CARTON (0378-6961-12) / 1 SYRINGE in 1 BLISTER PACK (0378-6961-32) / 1 mL in 1 SYRINGE |
| Marketing Start Date | 2017-10-04 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 130.152 |
| Pricing Unit | ML |
| Effective Date | 2023-12-20 |
| NDC Description | GLATIRAMER 40 MG/ML SYRINGE |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 4, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |