Bivalirudin in 0.9% Sodium Chloride
- Product NDC
- 0338-9576
- 11-digit product format
- 003389576
- Labeler code
- 0338
- Product ID
- 0338-9576_68a6b49d-9eb8-4d19-9b4a-41f17572b438
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bivalirudin in 0.9% Sodium Chloride Injection
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Baxter Healthcare Corporation
- Application
- NDA208374
- Marketing category
- NDA
- Marketing start
- 2017-12-21
- Marketing end
- 0000-00-00
- Substance
- BIVALIRUDIN
- Active strength
- 500 mg/100mL
- Pharmacologic classes
- Anti-coagulant [EPC], Direct Thrombin Inhibitor [EPC], Thrombin Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0338-9576-12 | 00338957612 | 12 BAG in 1 CARTON (0338-9576-12) > 100 mL in 1 BAG | 12 bag | 2017-12-21 | 0000-00-00 | No | No | Current |