Bivalirudin
- Product NDC
- 52958-034
- 11-digit product format
- 529580034
- Labeler code
- 52958
- Product ID
- 52958-034_463422b6-e6d2-4319-a95e-aed834c2c844
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bivalirudin
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hainan Shuangcheng Pharmaceuticals Co., Ltd.
- Application
- ANDA210031
- Marketing category
- ANDA
- Marketing start
- 2019-10-23
- 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 |
|---|
| 52958-034-01 | Bivalirudin | 10 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 10 | | 5 |
| 52958-034-01 | Bivalirudin | 1 in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52958-034 | BIVALIRUDIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HAINAN SHUANGCHENG PHARMACEUTICALS CO., LTD.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241224_61de12ff-e280-4bab-9804-43869ec45fa7.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 |
|---|
| 52958-034-01 | 52958003401 | 10 VIAL, SINGLE-USE in 1 CARTON (52958-034-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE | 2019-10-23 | 0000-00-00 | No | No | Current |