bivalirudin
- Product NDC
- 0781-9158
- 11-digit product format
- 007819158
- Labeler code
- 0781
- Product ID
- 0781-9158_77e2ae87-3dbd-46dd-b745-9eea5fb9b2f1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bivalirudin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Sandoz Inc
- Application
- NDA020873
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2015-10-23
- 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
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BIVALIRUDIN | ACTIVE INGREDIENT | TN9BEX005G | BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ] | 1 | |
| BIVALIRUDIN | ACTIVE MOIETY | TN9BEX005G | BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ] | 1 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0781-9158 | BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SANDOZ INC] | 4 | Legacy NDC | 20191003_2990d917-666b-4b84-8f54-605a299e3790.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0781-9158-95 | 00781915895 | 10 VIAL, SINGLE-USE in 1 CARTON (0781-9158-95) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE (0781-9158-94) | 2015-10-23 | 0000-00-00 | No | No | Current |