GLATIRAMER ACETATE
- Product NDC
- 11797-765
- 11-digit product format
- 117970765
- Labeler code
- 11797
- Product ID
- 11797-765_1bf557de-bcff-476b-b7c3-c7f7b8ddbfb2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- glatiramer acetate
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Italfarmaco SpA
- Application
- ANDA208468
- Marketing category
- ANDA
- Marketing start
- 2025-11-10
- 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
- GLATIRAMER ACETATE
- 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, 1487361 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 11797-765-03 | GLATIRAMER ACETATE | 1 mL in 1 SYRINGE | INJECTION, SOLUTION | 1 | | 1 |
| 11797-765-03 | GLATIRAMER ACETATE | 12 in 1 CARTON | INJECTION, SOLUTION | 12 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 11797-765-03 | 11797076503 | 12 SYRINGE in 1 CARTON (11797-765-03) / 1 mL in 1 SYRINGE | 12 syringe | 2025-11-10 | No | No | Historical |