BORTEZOMIB
- Product NDC
- 70771-1708
- 11-digit product format
- 707711708
- Labeler code
- 70771
- Product ID
- 70771-1708_a7ff2205-566b-4fb5-8f33-bf73377ee093
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BORTEZOMIB
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Zydus Lifesciences Limited
- 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 |
|---|
| 70771-1708-1 | BORTEZOMIB | 3.5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 3.5 | | 1 |
| 70771-1708-1 | BORTEZOMIB | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1708 | BORTEZOMIB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ZYDUS LIFESCIENCES LIMITED] | 1 | Current NDC, Legacy NDC, 2 package rows | 20220505_582c7c0d-fa25-4586-8157-a1e2653d72d9.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 |
|---|
| 70771-1708-1 | 70771170801 | 1 VIAL, SINGLE-DOSE in 1 CARTON (70771-1708-1) / 3.5 mL in 1 VIAL, SINGLE-DOSE | 2022-05-02 | 0000-00-00 | No | No | Current |