Irinotecan Hydrochloride
- Product NDC
- 25021-230
- 11-digit product format
- 250210230
- Labeler code
- 25021
- Product ID
- 25021-230_beff4b0b-e884-4134-ba9e-290020a94add
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- irinotecan hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Sagent Pharmaceuticals
- Application
- ANDA090675
- Marketing category
- ANDA
- Marketing start
- 2014-08-15
- Marketing end
- 2026-10-31
- Substance
- IRINOTECAN HYDROCHLORIDE
- Active strength
- 20 mg/mL
- Pharmacologic classes
- Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Irinotecan Hydrochloride
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IRINOTECAN HYDROCHLORIDE | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 042LAQ1IIS |
| Rxcui | 1726319, 1726324 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 25021-230-02 | Irinotecan Hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 12 |
| 25021-230-02 | Irinotecan Hydrochloride | 2 mL in 1 VIAL | INJECTION, SOLUTION | 2 | | 12 |
| 25021-230-05 | Irinotecan Hydrochloride | 5 mL in 1 VIAL | INJECTION, SOLUTION | 5 | | 12 |
| 25021-230-05 | Irinotecan Hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 12 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 25021-230 | IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS] | 11 | Current NDC, Legacy NDC, 4 package rows | 20250212_caab50e6-0dad-4ddd-9a6c-96cc2b87aee7.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 |
|---|
| 25021-230-02 | 25021023002 | 1 VIAL in 1 CARTON (25021-230-02) / 2 mL in 1 VIAL | 1 vial | 2014-08-15 | 2026-10-31 | No | No | Current |
| 25021-230-05 | 25021023005 | 1 VIAL in 1 CARTON (25021-230-05) / 5 mL in 1 VIAL | 1 vial | 2014-08-15 | 2026-08-31 | No | No | Current |