Doxorubicin Hydrochloride
- Product NDC
- 63323-101
- 11-digit product format
- 633230101
- Labeler code
- 63323
- Product ID
- 63323-101_89998b96-8ca7-4eb1-98a4-e533420d0e72
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- DOXORUBICIN HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA063277
- Marketing category
- ANDA
- Marketing start
- 2000-06-14
- 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 | 1191138, 1790097, 1790099, 1790100 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-101-61 | Doxorubicin Hydrochloride | 100 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 100 | | 5 |
| 63323-101-61 | Doxorubicin Hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-101 | DOXORUBICIN HYDROCHLORIDE (DOXORUBICIN HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241018_e0349f98-42fa-4003-b6d8-a1db1401b0ef.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 |
|---|
| 63323-101-61 | 63323010161 | 1 VIAL, MULTI-DOSE in 1 CARTON (63323-101-61) / 100 mL in 1 VIAL, MULTI-DOSE | 2000-06-14 | 0000-00-00 | No | No | Current |