Bortezomib
- Product NDC
- 70069-836
- 11-digit product format
- 700690836
- Labeler code
- 70069
- Product ID
- 70069-836_34c615d6-ddc9-c4b5-e063-6294a90a047f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bortezomib
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Somerset Therapeutics LLC
- Application
- ANDA211898
- Marketing category
- ANDA
- Marketing start
- 2025-04-29
- 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 |
|---|
| 70069-836-01 | Bortezomib | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 1 |
| 70069-836-01 | Bortezomib | 3.5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 3.5 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70069-836 | BORTEZOMIB (BORTEZOMIB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SOMERSET THERAPEUTICS LLC] | 1 | Current NDC, 2 package rows | 20250511_dc737d3d-2a4e-448a-ad70-e013065c411c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70069-836-01 | 70069083601 | 1 VIAL in 1 CARTON (70069-836-01) / 3.5 mL in 1 VIAL | 1 vial | 2025-04-29 | No | No | Current |