Bivalirudin
- Product NDC
- 60505-6101
- 11-digit product format
- 605056101
- Labeler code
- 60505
- Product ID
- 60505-6101_e1032ac4-affd-767b-4960-b26ecbaab80f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bivalirudin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Apotex corp
- Application
- ANDA204876
- Marketing category
- ANDA
- Marketing start
- 2017-07-17
- Marketing end
- 2021-03-01
- Substance
- BIVALIRUDIN
- Active strength
- 250 mg/1
- Pharmacologic classes
- Anti-coagulant [EPC],Direct Thrombin Inhibitor [EPC],Thrombin Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 60505-6101-4 | 60505610104 | 10 VIAL, SINGLE-DOSE in 1 CARTON (60505-6101-4) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE | 2017-07-17 | 2021-03-01 | No | No | Current |