BENDAMUSTINE HYDROCHLORIDE
- Product NDC
- 10019-079
- 11-digit product format
- 100190079
- Labeler code
- 10019
- Product ID
- 10019-079_007f13c9-9ca3-45f9-bbae-6806681efd06
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bendamustine hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Baxter Healthcare Corporation
- Application
- NDA216078
- Marketing category
- NDA
- Marketing start
- 2022-12-15
- Substance
- BENDAMUSTINE HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Alkylating Activity [MoA], Alkylating Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BENDAMUSTINE HYDROCHLORIDE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENDAMUSTINE HYDROCHLORIDE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 981Y8SX18M |
| Rxcui | 1726097 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10019-079-01 | BENDAMUSTINE HYDROCHLORIDE | 1 in 1 VIAL, MULTI-DOSE | INJECTION | 1 | | 11 |
| 10019-079-01 | BENDAMUSTINE HYDROCHLORIDE | 1 in 1 CARTON | INJECTION | 1 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10019-079 | BENDAMUSTINE HYDROCHLORIDE INJECTION [BAXTER HEALTHCARE CORPORATION] | 9 | Current NDC, Legacy NDC, 2 package rows | 20250507_766b73e2-49bb-47f9-bbb1-44cfa1a3197e.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 |
|---|
| 10019-079-01 | 10019007901 | 1 VIAL, MULTI-DOSE in 1 CARTON (10019-079-01) / 1 INJECTION in 1 VIAL, MULTI-DOSE | 2022-12-15 | 0000-00-00 | No | No | Current |