BORTEZOMIB
- Product NDC
- 60505-6050
- 11-digit product format
- 605056050
- Labeler code
- 60505
- Product ID
- 60505-6050_93afcbae-d69f-36b4-8470-ef4ea151e72b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bortezomib
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Apotex Corp
- Application
- ANDA205533
- Marketing category
- ANDA
- Marketing start
- 2022-05-02
- Substance
- BORTEZOMIB
- Active strength
- 3.5 mg/1
- 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 |
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 |
|---|
| 60505-6050-4 | BORTEZOMIB | 1 in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 1 | | 6 |
| 60505-6050-4 | BORTEZOMIB | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60505-6050 | BORTEZOMIB (BORTEZOMIB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [APOTEX CORP ] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241018_b605b541-4bfd-db3e-9710-11c27f6dee6c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 60505-6050-4 | 60505605004 | 1 VIAL in 1 CARTON (60505-6050-4) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL | 1 vial | 2022-05-02 | 0000-00-00 | No | No | Current |