Bortezomib
- Product NDC
- 68001-541
- 11-digit product format
- 680010541
- Labeler code
- 68001
- Product ID
- 68001-541_3b3aa2dc-f2db-2e48-e063-6394a90a41a2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bortezomib
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- BluePoint Laboratories
- Application
- ANDA209622
- Marketing category
- ANDA
- Marketing start
- 2022-07-31
- Substance
- BORTEZOMIB
- Active strength
- 3.5 mg/3.5mL
- 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/3.5mL |
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 |
|---|
| 68001-541-36 | Bortezomib | 3.5 mL in 1 VIAL, SINGLE-USE | INJECTION, POWDER, LYOPHILIZED, | 3.5 | | 2 |
| 68001-541-36 | Bortezomib | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68001-541 | BORTEZOMIB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [BLUEPOINT LABORATORIES] | 1 | Current NDC, Legacy NDC, 2 package rows | 20220819_c6b620c6-f3d6-4ff3-b46a-50a66e6d41dd.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 |
|---|
| 68001-541-36 | 68001054136 | 1 VIAL, SINGLE-USE in 1 CARTON (68001-541-36) / 3.5 mL in 1 VIAL, SINGLE-USE | 2022-07-31 | 0000-00-00 | No | No | Current |