Bortezomib
- Product NDC
- 83090-008
- 11-digit product format
- 830900008
- Labeler code
- 83090
- Product ID
- 83090-008_074a288f-8a8f-7c41-e063-6294a90a68dc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bortezomib
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Sintetica US LLC
- Application
- ANDA209622
- Marketing category
- ANDA
- Marketing start
- 2023-07-15
- Substance
- BORTEZOMIB
- Active strength
- 3.5 mg/3.5mL
- 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/3.5mL |
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 |
|---|
| 83090-008-01 | Bortezomib | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
| 83090-008-01 | Bortezomib | 3.5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 3.5 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83090-008 | BORTEZOMIB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SINTETICA US LLC] | 2 | Current NDC, 2 package rows | 20231109_d79a71ec-b46d-4961-ad05-8980915cba94.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 83090-008-01 | 83090000801 | 1 VIAL, SINGLE-DOSE in 1 CARTON (83090-008-01) / 3.5 mL in 1 VIAL, SINGLE-DOSE | 2023-07-15 | No | No | Current |