bendamustine hydrochloride
- Product NDC
- 16729-251
- 11-digit product format
- 167290251
- Labeler code
- 16729
- Product ID
- 16729-251_1d8759d2-4d4d-78ee-e063-6294a90a53ae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bendamustine hydrochloride
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Accord Healthcare, Inc.
- Application
- ANDA205574
- Marketing category
- ANDA
- Marketing start
- 2022-12-07
- Substance
- BENDAMUSTINE HYDROCHLORIDE
- Active strength
- 100 mg/20mL
- 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
- bendamustine hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENDAMUSTINE HYDROCHLORIDE | 100 mg/20mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 981Y8SX18M |
| Rxcui | 1805001, 1805007 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16729-251-05 | bendamustine hydrochloride | 1 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 1 | | 6 |
| 16729-251-05 | bendamustine hydrochloride | 20 mL in 1 VIAL, SINGLE-DOSE | INJECTION, POWDER, LYOPHILIZED, | 20 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16729-251 | BENDAMUSTINE HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACCORD HEALTHCARE, INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240719_33867f0f-f317-1fd0-e054-00144ff8d46c.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 |
|---|
| 16729-251-05 | 16729025105 | 1 VIAL, SINGLE-DOSE in 1 CARTON (16729-251-05) / 20 mL in 1 VIAL, SINGLE-DOSE | 2022-12-07 | 0000-00-00 | No | No | Current |