BORTEZOMIB
- Product NDC
- 0409-1703
- 11-digit product format
- 004091703
- Labeler code
- 0409
- Product ID
- 0409-1703_e7c31651-e301-43f9-bc81-e0fd5dcb828c
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BORTEZOMIB
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Hospira, Inc.
- Application
- NDA209191
- Marketing category
- NDA
- Marketing start
- 2022-05-16
- Substance
- BORTEZOMIB
- Active strength
- 2.5 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 | 2.5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 69G8BD63PP |
| Rxcui | 2601542, 2601544 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0409-1703-01 | BORTEZOMIB | 1 in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 3 |
| 0409-1703-01 | 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 |
|---|
| 0409-1703 | BORTEZOMIB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HOSPIRA, INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20230308_9fdf6169-699f-40eb-bda1-760253062b3c.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 |
|---|
| 0409-1703-01 | 00409170301 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0409-1703-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE | 2022-05-16 | 0000-00-00 | No | No | Current |