Doxorubicin hydrochloride
- Product NDC
- 45963-733
- 11-digit product format
- 459630733
- Labeler code
- 45963
- Product ID
- 45963-733_2ad7c99b-8cea-4e22-826f-9e49c90605b6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxorubicin hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA203622
- Marketing category
- ANDA
- Marketing start
- 2014-11-01
- 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 |
|---|
| 45963-733-55 | Doxorubicin hydrochloride | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | | 16 |
| 45963-733-55 | Doxorubicin hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 16 |
| 45963-733-57 | Doxorubicin hydrochloride | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 10 | | 16 |
| 45963-733-57 | Doxorubicin hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 16 |
| 45963-733-60 | Doxorubicin hydrochloride | 100 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 100 | | 16 |
| 45963-733-60 | Doxorubicin hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 16 |
| 45963-733-68 | Doxorubicin hydrochloride | 25 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 25 | | 16 |
| 45963-733-68 | Doxorubicin hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 16 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DOXORUBICIN HYDROCHLORIDE | ACTIVE INGREDIENT | 82F2G7BL4E | DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.] | 4 | |
| DOXORUBICIN | ACTIVE MOIETY | 80168379AG | DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.] | 4 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.] | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 45963-733 | DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [ACTAVIS PHARMA, INC.] | 16 | Current NDC, Legacy NDC, 8 package rows | 20241109_33ddfdb1-b4bc-464d-a186-49c4b156279f.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 |
|---|
| 45963-733-55 | 45963073355 | 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-733-55) / 5 mL in 1 VIAL, SINGLE-DOSE | 2014-11-01 | 0000-00-00 | No | No | Current |
| 45963-733-57 | 45963073357 | 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-733-57) / 10 mL in 1 VIAL, SINGLE-DOSE | 2014-11-01 | 0000-00-00 | No | No | Current |
| 45963-733-60 | 45963073360 | 1 VIAL, MULTI-DOSE in 1 CARTON (45963-733-60) / 100 mL in 1 VIAL, MULTI-DOSE | 2014-11-01 | 0000-00-00 | No | No | Current |
| 45963-733-68 | 45963073368 | 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-733-68) / 25 mL in 1 VIAL, SINGLE-DOSE | 2014-11-01 | 0000-00-00 | No | No | Current |