Glatiramer Acetate
- Product NDC
- 0832-6085
- 11-digit product format
- 008326085
- Labeler code
- 0832
- Product ID
- 0832-6085_991aa361-3f99-42cd-948b-5b1271b346c5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glatiramer Acetate Injection
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- UPSHER-SMITH LABORATORIES, LLC
- Application
- ANDA214741
- Marketing category
- ANDA
- Marketing start
- 2026-01-23
- Substance
- GLATIRAMER ACETATE
- Active strength
- 40 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Glatiramer Acetate
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GLATIRAMER ACETATE | 40 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5M691HL4BO |
| Rxcui | 1111641, 1487361 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0832-6085-12 | Glatiramer Acetate | 12 in 1 CARTON | INJECTION, SOLUTION | 12 | | 8 |
| 0832-6085-89 | Glatiramer Acetate | 1 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 1 | | 8 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0832-6085-12 | 00832608512 | 12 SYRINGE, GLASS in 1 CARTON (0832-6085-12) / 1 mL in 1 SYRINGE, GLASS (0832-6085-89) | | 2026-01-23 | No | No | Current |
| 0832-6085-89 | 00832608589 | 1 mL in 1 SYRINGE, GLASS | 1 ml | | | | Historical |