REPATHA
- Product NDC
- 72511-393
- 11-digit product format
- 725110393
- Labeler code
- 72511
- Product ID
- 72511-393_d9a0c476-16cf-46ae-8525-a89da9d76fc4
- 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
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| LKC0U3A8NJ | EVOLOCUMAB | 1256937-27-5 | EVOLOCUMAB |
Packages
| 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 | Historical |
| 72511-393-02 | 72511039302 | 2 SYRINGE in 1 CARTON (72511-393-02) / 1 mL in 1 SYRINGE | 2 syringe | 2024-11-24 | No | No | Historical |
| 72511-393-96 | 72511039396 | 1 SYRINGE in 1 CARTON (72511-393-96) / 1 mL in 1 SYRINGE | 1 syringe | 2024-11-24 | Yes | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| REPATHA | Amgen USA Inc. | Amgen, Inc | Amgen Manufacturing Limited LLC | 2026-01-22 | HUMAN PRESCRIPTION DRUG LABEL | 27 |