Bendeka
- Product NDC
- 63459-348
- 11-digit product format
- 634590348
- Labeler code
- 63459
- Product ID
- 63459-348_bcfd315e-9ade-4659-9f1c-dfb687ba39de
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bendamustine hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Application
- NDA208194
- Marketing category
- NDA
- Marketing start
- 2015-12-08
- 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
- Bendeka
- 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, 1726102 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63459-348-04 | Bendeka | 4 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 4 | | 22 |
| 63459-348-04 | Bendeka | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 22 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63459-348 | BENDEKA (BENDAMUSTINE HYDROCHLORIDE) INJECTION, SOLUTION [TEVA PHARMACEUTICALS USA, INC.] | 22 | Current NDC, Legacy NDC, 2 package rows | 20240124_ace9a43b-f9bd-4896-abfe-0ef4fec67ddf.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 |
|---|
| 63459-348-04 | 63459034804 | 1 VIAL, MULTI-DOSE in 1 CARTON (63459-348-04) / 4 mL in 1 VIAL, MULTI-DOSE | 2015-12-08 | 0000-00-00 | No | No | Current |