REPATHA
- Product NDC
- 72511-393
- 11-digit product format
- 725110393
- Labeler code
- 72511
- Product ID
- 72511-393_06ed6b58-e662-4be7-82bf-30fb4265534a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Evolocumab
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Amgen USA Inc.
- Application
- BLA125522
- Marketing category
- BLA
- Marketing start
- 2024-11-24
- Substance
- EVOLOCUMAB
- Active strength
- 140 mg/mL
- Pharmacologic classes
- Antibodies, Monoclonal [CS], PCSK9 Inhibitor [EPC], PCSK9 Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- REPATHA
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| EVOLOCUMAB | 140 mg/mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72511-393-01 | REPATHA | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 27 |
| 72511-393-01 | REPATHA | 1 mL in 1 SYRINGE | INJECTION, SOLUTION | 1 | | 27 |
| 72511-393-02 | REPATHA | 1 mL in 1 SYRINGE | INJECTION, SOLUTION | 1 | | 27 |
| 72511-393-02 | REPATHA | 2 in 1 CARTON | INJECTION, SOLUTION | 2 | | 27 |
| 72511-393-96 | REPATHA | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 27 |
| 72511-393-96 | REPATHA | 1 mL in 1 SYRINGE | INJECTION, SOLUTION | 1 | | 27 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72511-393 | REPATHA (EVOLOCUMAB) INJECTION, SOLUTION REPATHA (EVOLOCUMAB) KIT [AMGEN USA INC.] | 24 | Current NDC, 6 package rows | 20250524_cd61e902-166d-4aa6-9f3c-a18c1008d07e.zip |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125522 | Repatha | evolocumab | 351(a) | Rx | 2026-10-01 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72511-393-01 | 72511039301 | 1 SYRINGE in 1 CARTON (72511-393-01) / 1 mL in 1 SYRINGE | 1 syringe | 2024-11-24 | No | No | Current |
| 72511-393-02 | 72511039302 | 2 SYRINGE in 1 CARTON (72511-393-02) / 1 mL in 1 SYRINGE | 2 syringe | 2024-11-24 | No | No | Current |
| 72511-393-96 | 72511039396 | 1 SYRINGE in 1 CARTON (72511-393-96) / 1 mL in 1 SYRINGE | 1 syringe | 2024-11-24 | Yes | No | Current |