bivalirudin
- Product NDC
- 25021-405
- 11-digit product format
- 250210405
- Labeler code
- 25021
- Product ID
- 25021-405_cf5f5040-329b-43a3-9ec8-22b1fdc454dd
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bivalirudin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Sagent Pharmaceuticals
- Application
- ANDA091602
- Marketing category
- ANDA
- Marketing start
- 2019-01-15
- 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