Daunorubicin Hydrochloride
- Product NDC
- 0143-9551
- 11-digit product format
- 001439551
- Labeler code
- 0143
- Product ID
- 0143-9551_d77dc365-6db8-4bdc-81fc-7ac80bcc7699
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Daunorubicin Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- NDA050731
- Marketing category
- NDA
- Marketing start
- 2018-01-02
- Substance
- DAUNORUBICIN HYDROCHLORIDE
- Active strength
- 5 mg/mL
- Pharmacologic classes
- Anthracycline Topoisomerase Inhibitor [EPC], Anthracyclines [CS], Topoisomerase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Daunorubicin Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DAUNORUBICIN HYDROCHLORIDE | 5 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | UD984I04LZ |
| Rxcui | 309650, 2002002 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0143-9551-01 | Daunorubicin Hydrochloride | 4 mL in 1 VIAL | INJECTION | 4 | | 6 |
| 0143-9551-10 | Daunorubicin Hydrochloride | 10 in 1 BOX | INJECTION | 10 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9551 | DAUNORUBICIN HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240216_227784a8-ce68-4dd4-8ac5-a65265969677.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0143-9551-01 | 00143955101 | 4 mL in 1 VIAL | 4 ml | | | | | Historical |
| 0143-9551-10 | 00143955110 | 10 VIAL in 1 BOX (0143-9551-10) / 4 mL in 1 VIAL (0143-9551-01) | 10 vial | 2018-01-02 | 0000-00-00 | No | No | Current |