VIVIMUSTA
- Product NDC
- 71225-120
- 11-digit product format
- 712250120
- Labeler code
- 71225
- Product ID
- 71225-120_c4b54079-dac2-4e01-a00f-6ceaa788f605
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- BENDAMUSTINE HYDROCHLORIDE
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Slayback Pharma LLC
- Application
- NDA212209
- Marketing category
- NDA
- Marketing start
- 2022-12-07
- Substance
- BENDAMUSTINE HYDROCHLORIDE
- Active strength
- 25 mg/mL
- Pharmacologic classes
- Alkylating Activity [MoA], Alkylating Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- VIVIMUSTA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENDAMUSTINE HYDROCHLORIDE | 25 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 981Y8SX18M |
| Rxcui | 1726097, 2622914 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71225-120-01 | VIVIMUSTA | 1 in 1 CARTON | INJECTION | 1 | | 22 |
| 71225-120-01 | VIVIMUSTA | 4 mL in 1 VIAL, MULTI-DOSE | INJECTION | 4 | | 22 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71225-120 | VIVIMUSTA (BENDAMUSTINE HYDROCHLORIDE) INJECTION [SLAYBACK PHARMA LLC] | 22 | Current NDC, Legacy NDC, 2 package rows | 20240925_cbcc6eb7-aa62-4599-af49-05203fedb4bb.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 |
|---|
| 71225-120-01 | 71225012001 | 1 VIAL, MULTI-DOSE in 1 CARTON (71225-120-01) / 4 mL in 1 VIAL, MULTI-DOSE | 2022-12-07 | 0000-00-00 | No | No | Current |