TREANDA
- Product NDC
- 63459-390
- 11-digit product format
- 634590390
- Labeler code
- 63459
- Product ID
- 63459-390_77ae475d-2d59-4fe2-8de7-833b6fc9d51a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Bendamustine Hydrochloride
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Cephalon, LLC
- Application
- NDA022249
- Marketing category
- NDA
- Marketing start
- 2010-01-05
- Substance
- BENDAMUSTINE HYDROCHLORIDE
- Active strength
- 25 mg/5mL
- 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
- TREANDA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENDAMUSTINE HYDROCHLORIDE | 25 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 981Y8SX18M |
| Rxcui | 1805001, 1805004, 1805007, 1805009, 1805011, 1805012, 1805015, 1805016 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63459-390-08 | TREANDA | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 5 | | 26 |
| 63459-390-08 | TREANDA | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 26 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| BENDAMUSTINE HYDROCHLORIDE | ACTIVE INGREDIENT | 981Y8SX18M | TREANDA (BENDAMUSTINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE TREANDA (BENDAMUSTINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CEPHALON, INCORPORATED] | 15 | |
| BENDAMUSTINE | ACTIVE MOIETY | 9266D9P3PQ | TREANDA (BENDAMUSTINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE TREANDA (BENDAMUSTINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CEPHALON, INCORPORATED] | 15 | |
| MANNITOL | INACTIVE INGREDIENT | 3OWL53L36A | TREANDA (BENDAMUSTINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE TREANDA (BENDAMUSTINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CEPHALON, INCORPORATED] | 15 | |
| N,N-DIMETHYLACETAMIDE | INACTIVE INGREDIENT | JCV5VDB3HY | TREANDA (BENDAMUSTINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE TREANDA (BENDAMUSTINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CEPHALON, INCORPORATED] | 15 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | TREANDA (BENDAMUSTINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE TREANDA (BENDAMUSTINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CEPHALON, INCORPORATED] | 15 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63459-390 | TREANDA (BENDAMUSTINE HYDROCHLORIDE) INJECTION, SOLUTION, CONCENTRATE TREANDA (BENDAMUSTINE HYDROCHLORIDE) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [CEPHALON, LLC] | 26 | Current NDC, Legacy NDC, 2 package rows | 20221029_39d53698-57fa-7c99-fc5b-f52a55684826.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 |
|---|
| 63459-390-08 | 63459039008 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63459-390-08) / 5 mL in 1 VIAL, SINGLE-DOSE | 2010-01-05 | 0000-00-00 | No | No | Current |