Idarubicin Hydrochloride
- Product NDC
- 0143-9306
- 11-digit product format
- 001439306
- Labeler code
- 0143
- Product ID
- 0143-9306_c78bf879-433f-4805-ad7b-5fa3002a75db
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Idarubicin Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA065275
- Marketing category
- ANDA
- Marketing start
- 2018-01-12
- Substance
- IDARUBICIN HYDROCHLORIDE
- Active strength
- 1 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
- Idarubicin Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IDARUBICIN HYDROCHLORIDE | 1 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 5VV3MDU5IE |
| Rxcui | 1791493, 1791498, 1791500 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0143-9306-01 | Idarubicin Hydrochloride | 5 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 5 | | 4 |
| 0143-9306-01 | Idarubicin Hydrochloride | 1 in 1 BOX | INJECTION, SOLUTION | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9306 | IDARUBICIN HYDROCHLORIDE INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20250109_7c20b574-285b-49eb-a98e-6752e4bb481d.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 |
|---|
| 0143-9306-01 | 00143930601 | 1 VIAL, GLASS in 1 BOX (0143-9306-01) / 5 mL in 1 VIAL, GLASS | 2018-01-12 | 0000-00-00 | No | No | Current |