REPATHA
- Product NDC
- 55513-760
- 11-digit product format
- 555130760
- Labeler code
- 55513
- Product ID
- 55513-760_e93d54e9-7f1c-4f07-b217-5ddcef89e16e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Evolocumab
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Amgen Inc
- Application
- BLA125522
- Marketing category
- BLA
- Marketing start
- 2015-08-31
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55513-760-01 | 55513076001 | 1 SYRINGE in 1 CARTON (55513-760-01) > 1 mL in 1 SYRINGE | 1 syringe | 2015-08-31 | 0000-00-00 | No | No | Current |
| 55513-760-02 | 55513076002 | 2 SYRINGE in 1 CARTON (55513-760-02) > 1 mL in 1 SYRINGE | 2 syringe | 2015-08-31 | 0000-00-00 | No | No | Current |
| 55513-760-03 | 55513076003 | 3 SYRINGE in 1 CARTON (55513-760-03) > 1 mL in 1 SYRINGE | 3 syringe | 2015-08-31 | 0000-00-00 | No | No | Current |
| 55513-760-91 | 55513076091 | 1 SYRINGE in 1 CARTON (55513-760-91) > 1 mL in 1 SYRINGE | 1 syringe | 2015-08-31 | 0000-00-00 | Yes | No | Current |