Copaxone
- Product NDC
- 68546-325
- 11-digit product format
- 685460325
- Labeler code
- 68546
- Product ID
- 68546-325_5a691b1f-367f-4635-a7d6-0111361a2dbb
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glatiramer Acetate
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Teva Neuroscience, Inc.
- Application
- NDA020622
- Marketing category
- NDA
- Marketing start
- 2014-01-29
- Substance
- GLATIRAMER ACETATE
- Active strength
- 40 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Copaxone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GLATIRAMER ACETATE | 40 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5M691HL4BO |
| Rxcui | 1111641, 1111642, 1487361, 1487363 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68546-325-06 | Copaxone | 6 in 1 CARTON | INJECTION, SOLUTION | 6 | | 35 |
| 68546-325-06 | Copaxone | 1 in 1 BLISTER PACK | INJECTION, SOLUTION | 1 | | 35 |
| 68546-325-12 | Copaxone | 12 in 1 CARTON | INJECTION, SOLUTION | 12 | | 35 |
| 68546-325-12 | Copaxone | 1 in 1 BLISTER PACK | INJECTION, SOLUTION | 1 | | 35 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68546-325 | COPAXONE (GLATIRAMER ACETATE) INJECTION, SOLUTION [TEVA NEUROSCIENCE, INC.] | 35 | Current NDC, Legacy NDC, 4 package rows | 20250221_aa88f583-4f5f-433b-80b4-1f4c9fb28357.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 68546-325-06 | 68546032506 | 6 BLISTER PACK in 1 CARTON (68546-325-06) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS | 6 blister pack | 2014-01-29 | 0000-00-00 | No | No | Current |
| 68546-325-12 | 68546032512 | 12 BLISTER PACK in 1 CARTON (68546-325-12) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS | 12 blister pack | 2014-01-29 | 0000-00-00 | No | No | Current |