Doxorubicin Hydrochloride
- Product NDC
- 68083-248
- 11-digit product format
- 680830248
- Labeler code
- 68083
- Product ID
- 68083-248_b7814991-37d8-4928-ad83-d8fc04409c08
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Doxorubicin Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Gland Pharma Limited
- Application
- ANDA209825
- Marketing category
- ANDA
- Marketing start
- 2017-08-22
- 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, 1790127 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68083-248-01 | Doxorubicin Hydrochloride | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | | 12 |
| 68083-248-01 | Doxorubicin Hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68083-248 | DOXORUBICIN HYDROCHLORIDE INJECTION, SOLUTION [GLAND PHARMA LIMITED] | 12 | Current NDC, Legacy NDC, 2 package rows | 20240926_74b14803-afc8-4a2e-ba92-43f1a72025eb.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 |
|---|
| 68083-248-01 | 68083024801 | 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-248-01) / 5 mL in 1 VIAL, SINGLE-DOSE | 2017-08-22 | 0000-00-00 | No | No | Current |