bortezomib
- Product NDC
- 0143-9098
- 11-digit product format
- 001439098
- Labeler code
- 0143
- Product ID
- 0143-9098_e673dbf4-9d4e-4665-ac36-81c6537044fc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bortezomib
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA215011
- Marketing category
- ANDA
- Marketing start
- 2022-07-27
- Substance
- BORTEZOMIB
- Active strength
- 3.5 mg/1
- 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 | 3.5 mg/1 |
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 |
|---|
| 0143-9098-01 | bortezomib | 1 in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
| 0143-9098-01 | bortezomib | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9098 | BORTEZOMIB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20220728_854be921-5fd9-482a-8432-a0c0241625f8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0143-9098-01 | 00143909801 | 1 VIAL in 1 CARTON (0143-9098-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL | 1 vial | 2022-07-27 | 0000-00-00 | No | No | Current |