BIVALIRUDIN
- Product NDC
- 55150-210
- 11-digit product format
- 551500210
- Labeler code
- 55150
- Product ID
- 55150-210_eb82831b-a234-4818-bbf2-e75e45647b77
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BIVALIRUDIN
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Eugia US LLC
- Application
- ANDA205962
- Marketing category
- ANDA
- Marketing start
- 2018-07-27
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BIVALIRUDIN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BIVALIRUDIN | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | TN9BEX005G |
| Rxcui | 308769 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55150-210-10 | BIVALIRUDIN | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | | 8 |
| 55150-210-10 | BIVALIRUDIN | 1 in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-210 | BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC] | 8 | Current NDC, Legacy NDC, 2 package rows | 20241218_e574d04f-67b4-4a84-9d66-8c2d54f95120.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55150-210-10 | 55150021010 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-210-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE | 2018-07-27 | 0000-00-00 | No | No | Current |