Bortezomib
- Product NDC
- 83634-208
- 11-digit product format
- 836340208
- Labeler code
- 83634
- Product ID
- 83634-208_e6157e3e-7111-4e20-bdd8-2c7d74d5e7b4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bortezomib
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Avenacy, LLC
- Application
- ANDA216528
- Marketing category
- ANDA
- Marketing start
- 2026-05-01
- Substance
- BORTEZOMIB
- Active strength
- 3.5 mg/1
- Pharmacologic classes
- Proteasome Inhibitor [EPC], Proteasome Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Bortezomib
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BORTEZOMIB | 3.5 mg/1 |
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 |
|---|
| 83634-208-10 | Bortezomib | 1 in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1 | | 1 |
| 83634-208-10 | Bortezomib | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83634-208-10 | 83634020810 | 1 VIAL in 1 CARTON (83634-208-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL | 1 vial | 2026-05-01 | No | No | Current |