BORUZU
- Product NDC
- 70121-2484
- 11-digit product format
- 701212484
- Labeler code
- 70121
- Product ID
- 70121-2484_6fb2ce70-c98f-4e46-9b0f-6aec0530f61d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bortezomib
- Dosage form
- INJECTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- NDA212782
- Marketing category
- NDA
- Marketing start
- 2024-09-27
- Substance
- BORTEZOMIB
- Active strength
- 3.5 mg/1.4mL
- 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
- BORUZU
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BORTEZOMIB | 3.5 mg/1.4mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 69G8BD63PP |
| Rxcui | 2608948, 2693996 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70121-2484-1 | BORUZU | 1 in 1 CARTON | INJECTION | 1 | | 2 |
| 70121-2484-1 | BORUZU | 1.4 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 1.4 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70121-2484 | BORUZU (BORTEZOMIB) INJECTION [AMNEAL PHARMACEUTICALS LLC] | 1 | Current NDC, 2 package rows | 20240929_b92628dd-fa09-4c3a-b6a3-66426025807c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70121-2484-1 | 70121248401 | 1 VIAL, SINGLE-DOSE in 1 CARTON (70121-2484-1) / 1.4 mL in 1 VIAL, SINGLE-DOSE | 2024-09-27 | No | No | Current |