Doxorubicin Hydrochloride
- Product NDC
- 63323-883
- 11-digit product format
- 633230883
- Labeler code
- 63323
- Product ID
- 63323-883_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
- 2000-04-14
- 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 |
|---|
| 63323-883-05 | Doxorubicin Hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 5 |
| 63323-883-05 | Doxorubicin Hydrochloride | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | | 5 |
| 63323-883-10 | Doxorubicin Hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 5 |
| 63323-883-10 | Doxorubicin Hydrochloride | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | | 5 |
| 63323-883-30 | Doxorubicin Hydrochloride | 25 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 25 | | 5 |
| 63323-883-30 | Doxorubicin Hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 5 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DOXORUBICIN HYDROCHLORIDE | ACTIVE INGREDIENT | 82F2G7BL4E | DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| DOXORUBICIN | ACTIVE MOIETY | 80168379AG | DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-883 | DOXORUBICIN HYDROCHLORIDE (DOXORUBICIN HYDROCHLORIDE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 5 | Current NDC, Legacy NDC, 6 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 |
|---|
| 63323-883-05 | 63323088305 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-883-05) / 5 mL in 1 VIAL, SINGLE-DOSE | 2000-04-14 | 0000-00-00 | No | No | Current |
| 63323-883-10 | 63323088310 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-883-10) / 10 mL in 1 VIAL, SINGLE-DOSE | 2000-04-14 | 0000-00-00 | No | No | Current |
| 63323-883-30 | 63323088330 | 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-883-30) / 25 mL in 1 VIAL, SINGLE-DOSE | 2000-04-14 | 0000-00-00 | No | No | Current |