Irinotecan Hydrochloride
- Product NDC
- 0143-9583
- 11-digit product format
- 001439583
- Labeler code
- 0143
- Product ID
- 0143-9583_e36c07c2-a7ad-4d59-bdcc-fe16765b264b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irinotecan Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA091032
- Marketing category
- ANDA
- Marketing start
- 2010-12-20
- Substance
- IRINOTECAN HYDROCHLORIDE
- Active strength
- 20 mg/mL
- Pharmacologic classes
- Topoisomerase Inhibitor [EPC], 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
- Irinotecan Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IRINOTECAN HYDROCHLORIDE | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 042LAQ1IIS |
| Rxcui | 1726324 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0143-9583-01 | Irinotecan Hydrochloride | 5 mL in 1 VIAL, GLASS | INJECTION | 5 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0143-9583 | IRINOTECAN HYDROCHLORIDE INJECTION [HIKMA PHARMACEUTICALS USA INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20220820_9c6aa884-750e-4b11-9955-bc7ab6e9c2ad.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0143-9583-01 | 00143958301 | 5 mL in 1 VIAL, GLASS (0143-9583-01) | 5 ml | 2010-12-20 | 0000-00-00 | No | No | Current |