Doxorubicin Hydrochloride
- Product NDC
- 0069-4031
- 11-digit product format
- 000694031
- Labeler code
- 0069
- Product ID
- 0069-4031_d31d7f58-66d0-4826-b6b5-5914c031965f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxorubicin Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Pfizer Laboratories Div Pfizer Inc
- Application
- NDA050629
- Marketing category
- NDA
- Marketing start
- 2025-03-31
- 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 | 1790097, 1790099 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0069-4031-12 | Doxorubicin Hydrochloride | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | | 1 |
| 0069-4031-12 | Doxorubicin Hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0069-4031 | DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [PFIZER LABORATORIES DIV PFIZER INC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20250402_d31d7f58-66d0-4826-b6b5-5914c031965f.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 |
|---|
| 0069-4031-01 | 00069403101 | 1 VIAL, SINGLE-DOSE in 1 PACKAGE (0069-4031-01) > 10 mL in 1 VIAL, SINGLE-DOSE | 2013-03-05 | 0000-00-00 | No | No | Current |
| 0069-4031-12 | 00069403112 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0069-4031-12) / 10 mL in 1 VIAL, SINGLE-DOSE | 2025-03-31 | | No | No | Current |