Glatiramer Acetate
- Product NDC
- 47335-990
- 11-digit product format
- 473350990
- Labeler code
- 47335
- Product ID
- 47335-990_3b31bc9a-3536-4485-ae0d-05acf7c2787d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glatiramer Acetate
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA203857
- Marketing category
- ANDA
- Marketing start
- 2025-08-15
- Substance
- GLATIRAMER ACETATE
- Active strength
- 20 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 | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5M691HL4BO |
| Rxcui | 1111641 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 47335-990-02 | Glatiramer Acetate | 30 in 1 CARTON | INJECTION, SOLUTION | 30 | | 8 |
| 47335-990-02 | Glatiramer Acetate | 1 in 1 BLISTER PACK | 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 |
|---|
| 47335-990-02 | 47335099002 | 30 BLISTER PACK in 1 CARTON (47335-990-02) / 1 SYRINGE in 1 BLISTER PACK / 1 mL in 1 SYRINGE | 30 blister pack | 2025-08-15 | No | No | Historical |