BELRAPZO
- Product NDC
- 42367-521
- 11-digit product format
- 423670521
- Labeler code
- 42367
- Product ID
- 42367-521_7e2a2a05-9122-41c0-acf0-a1231a57434e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- bendamustine hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Eagle Pharmaceuticals, Inc
- Application
- NDA205580
- Marketing category
- NDA
- Marketing start
- 2019-06-03
- Substance
- BENDAMUSTINE HYDROCHLORIDE
- Active strength
- 100 mg/4mL
- 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
- BELRAPZO
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BENDAMUSTINE HYDROCHLORIDE | 100 mg/4mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 981Y8SX18M |
| Rxcui | 1726097, 2178266 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42367-521-25 | BELRAPZO | 1 in 1 CARTON | INJECTION | 1 | | 11 |
| 42367-521-25 | BELRAPZO | 4 mL in 1 VIAL, MULTI-DOSE | INJECTION | 4 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42367-521 | BELRAPZO (BENDAMUSTINE HYDROCHLORIDE) INJECTION [EAGLE PHARMACEUTICALS, INC] | 11 | Current NDC, Legacy NDC, 2 package rows | 20241003_9759a4ae-82ca-40cf-9c02-e1cadb21cbdc.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 |
|---|
| 42367-521-25 | 42367052125 | 1 VIAL, MULTI-DOSE in 1 CARTON (42367-521-25) / 4 mL in 1 VIAL, MULTI-DOSE | 2019-06-03 | 0000-00-00 | No | No | Current |