Doxorubicin Hydrochloride
- Product NDC
- 0143-9092
- 11-digit product format
- 001439092
- Labeler code
- 0143
- Product ID
- 0143-9092_3b0d5f19-5eab-4729-8fbf-3b988cbc6d04
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxorubicin Hydrochloride
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA062921
- Marketing category
- ANDA
- Marketing start
- 2018-01-19
- Substance
- DOXORUBICIN HYDROCHLORIDE
- Active strength
- 2 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
- Doxorubicin Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| DOXORUBICIN HYDROCHLORIDE | 2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 82F2G7BL4E |
| Rxcui | 1790095, 1790103 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0143-9092-01 | Doxorubicin Hydrochloride | 5 mL in 1 VIAL | INJECTION, POWDER, LYOPHILIZED, | 5 | | 3 |
| 0143-9092-01 | Doxorubicin Hydrochloride | 1 in 1 BOX | INJECTION, POWDER, LYOPHILIZED, | 1 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9092 | DOXORUBICIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20240427_f62aa88d-1e25-4049-87ec-99d42edd1d31.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 |
|---|
| 0143-9092-01 | 00143909201 | 1 VIAL in 1 BOX (0143-9092-01) / 5 mL in 1 VIAL | 1 vial | 2018-01-19 | 0000-00-00 | No | No | Current |