Bortezomib
- Product NDC
- 71288-118
- 11-digit product format
- 712880118
- Labeler code
- 71288
- Product ID
- 71288-118_27f6f56f-fefb-4caf-aee7-9e7e2a9c74f4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bortezomib
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Meitheal Pharmaceuticals Inc.
- Application
- ANDA212958
- Marketing category
- ANDA
- Marketing start
- 2022-07-26
- Marketing end
- 2026-11-19
- Substance
- BORTEZOMIB
- Active strength
- 3.5 mg/1
- Pharmacologic classes
- Proteasome Inhibitor [EPC], Proteasome Inhibitors [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Bortezomib
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 |
|---|
| 71288-118-10 | Bortezomib | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 6 |
| 71288-118-10 | Bortezomib | 1 in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71288-118 | BORTEZOMIB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20220729_322e315f-dd94-475f-94f4-4d86a7eb5590.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71288-118-10 | 71288011810 | 1 VIAL, SINGLE-DOSE in 1 CARTON (71288-118-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE | 2022-07-26 | 2026-11-19 | No | No | Current |