BORTEZOMIB
- Product NDC
- 55150-337
- 11-digit product format
- 551500337
- Labeler code
- 55150
- Product ID
- 55150-337_107c9155-9130-4202-b2e4-4c7732561420
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BORTEZOMIB
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Eugia US LLC
- Application
- ANDA212825
- 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 |
|---|
| 55150-337-01 | BORTEZOMIB | 1 in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 3 |
| 55150-337-01 | BORTEZOMIB | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 3 |
| 55150-337-02 | BORTEZOMIB | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 1 |
| 55150-337-02 | BORTEZOMIB | 1 in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-337 | BORTEZOMIB INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [EUGIA US LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20241208_76c7c3a5-fd2f-403f-85fd-65a64538eee7.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 |
|---|
| 55150-337-01 | 55150033701 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-337-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE | 2022-05-02 | 0000-00-00 | No | No | Current |
| 55150-337-02 | 55150033702 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-337-02) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE | 2022-05-02 | | No | No | Historical |