Glatiramer Acetate
- Product NDC
- 82983-430
- 11-digit product format
- 829830430
- Labeler code
- 82983
- Product ID
- 82983-430_596fb2ff-60b9-46f0-b5c7-00e3108e8f28
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- glatiramer acetate
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- AJENAT PHARMACEUTICALS LLC
- Application
- ANDA214022
- Marketing category
- ANDA
- Marketing start
- 2026-03-20
- 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 | 1487361 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 82983-430-01 | Glatiramer Acetate | 1 mL in 1 SYRINGE | INJECTION, SOLUTION | 1 | | 2 |
| 82983-430-01 | Glatiramer Acetate | 1 in 1 BLISTER PACK | INJECTION, SOLUTION | 1 | | 2 |
| 82983-430-12 | Glatiramer Acetate | 12 in 1 CARTON | INJECTION, SOLUTION | 12 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82983-430-01 | 82983043001 | 1 mL in 1 SYRINGE | 1 ml | | | | Historical |
| 82983-430-12 | 82983043012 | 12 BLISTER PACK in 1 CARTON (82983-430-12) / 1 SYRINGE in 1 BLISTER PACK (82983-430-01) / 1 mL in 1 SYRINGE | 12 blister pack | 2026-03-20 | No | No | Historical |