BORTEZOMIB
- Product NDC
- 70710-1411
- 11-digit product format
- 707101411
- Labeler code
- 70710
- Product ID
- 70710-1411_1d5e9573-97a5-4d8e-a9b1-80750b9870b3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BORTEZOMIB
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Zydus Pharmaceuticals USA Inc.
- Application
- ANDA210204
- Marketing category
- ANDA
- Marketing start
- 2022-05-02
- Substance
- BORTEZOMIB
- Active strength
- 1 mg/mL
- Pharmacologic classes
- Proteasome Inhibitor [EPC], Proteasome 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
- BORTEZOMIB
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BORTEZOMIB | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 69G8BD63PP |
| Rxcui | 402243 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70710-1411-1 | BORTEZOMIB | 3.5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 3.5 | | 3 |
| 70710-1411-1 | BORTEZOMIB | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70710-1411 | BORTEZOMIB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ZYDUS PHARMACEUTICALS USA INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241208_0eb8daef-18da-43bb-b7c6-38c4c8b5dd80.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 |
|---|
| 70710-1411-1 | 70710141101 | 1 VIAL, SINGLE-DOSE in 1 CARTON (70710-1411-1) / 3.5 mL in 1 VIAL, SINGLE-DOSE | 2022-05-02 | 0000-00-00 | No | No | Current |