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 ID | 68546-317_04f9ea25-0d45-4e44-8ed8-dc61db4f5466 |
| NDC | 68546-317 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Copaxone |
| Generic Name | Glatiramer Acetate |
| Dosage Form | Injection, Solution |
| Route of Administration | SUBCUTANEOUS |
| Marketing Start Date | 2008-04-28 |
| Marketing Category | NDA / NDA |
| Application Number | NDA020622 |
| Labeler Name | Teva Neuroscience, Inc. |
| Substance Name | GLATIRAMER ACETATE |
| Active Ingredient Strength | 20 mg/mL |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
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 Date | 2008-04-28 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 68546-317-00 [68546031700]
Copaxone INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020622 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2013-06-04 |
| Marketing End Date | 2015-02-28 |
NDC 68546-317-30 [68546031730]
Copaxone INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA020622 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2008-04-28 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| GLATIRAMER ACETATE | 20 mg/mL |
OpenFDA Data
| SPL SET ID: | aa88f583-4f5f-433b-80b4-1f4c9fb28357 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
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"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 68546-317 | Copaxone | Glatiramer Acetate |
| 68546-325 | Copaxone | Glatiramer Acetate |
| 0378-6960 | Glatiramer Acetate | glatiramer acetate |
| 0781-3234 | Glatopa | Glatiramer Acetate |
| 0781-3250 | Glatopa | Glatiramer Acetate |
| 63629-8815 | Glatopa | Glatiramer Acetate |
| 63629-8816 | Glatopa | Glatiramer Acetate |
Trademark Results [Copaxone]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 COPAXONE 74348964 1816603 Live/Registered |
TEVA PHARMACEUTICAL INDUSTRIES LTD. 1993-01-15 |
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