Bortezomib
- Product NDC
- 63759-3032
- 11-digit product format
- 637593032
- Labeler code
- 63759
- Product ID
- 63759-3032_71ebcbb5-31e2-4394-8a38-d833fd3c733a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bortezomib
- Dosage form
- INJECTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Shilpa Medicare Limited
- Application
- NDA212782
- Marketing category
- NDA
- Marketing start
- 2024-09-25
- 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
- Bortezomib
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63759-3032-1 | Bortezomib | 1 in 1 CARTON | INJECTION | 1 | | 1 |
| 63759-3032-1 | Bortezomib | 1.4 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 1.4 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63759-3032 | BORTEZOMIB INJECTION [SHILPA MEDICARE LIMITED] | 1 | Current NDC, 2 package rows | 20240926_61539d49-dc21-4576-8813-4bc8abf3868c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 63759-3032-1 | 63759303201 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63759-3032-1) / 1.4 mL in 1 VIAL, SINGLE-DOSE | 2024-09-25 | No | No | Current |