bivalirudin
- Product NDC
- 69097-601
- 11-digit product format
- 690970601
- Labeler code
- 69097
- Product ID
- 69097-601_cd8da81e-b4c8-44ce-b425-2b3f693dd244
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bivalirudin
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Cipla USA Inc.
- Application
- ANDA091602
- Marketing category
- ANDA
- Marketing start
- 2018-07-16
- Marketing end
- 0000-00-00
- 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
- 2020-12-31
- Current FDA listing
- Historical FDA.report record