Irinotecan Hydrochloride
- Product NDC
- 61703-349
- 11-digit product format
- 617030349
- Labeler code
- 61703
- Product ID
- 61703-349_9c52ca8e-58dd-4117-a5bc-f277e79abb19
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irinotecan Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hospira, Inc.
- Application
- ANDA077915
- Marketing category
- ANDA
- Marketing start
- 2008-02-27
- 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 | 1726319, 1726324, 1726492 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61703-349-09 | Irinotecan Hydrochloride | 5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 5 | | 26 |
| 61703-349-09 | Irinotecan Hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 26 |
| 61703-349-16 | Irinotecan Hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 26 |
| 61703-349-16 | Irinotecan Hydrochloride | 2 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 2 | | 26 |
| 61703-349-36 | Irinotecan Hydrochloride | 25 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 25 | | 26 |
| 61703-349-36 | Irinotecan Hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 26 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| IRINOTECAN HYDROCHLORIDE | ACTIVE INGREDIENT | 042LAQ1IIS | IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.] | 12 | |
| IRINOTECAN | ACTIVE MOIETY | 7673326042 | IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.] | 12 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.] | 12 | |
| LACTIC ACID, UNSPECIFIED FORM | INACTIVE INGREDIENT | 33X04XA5AT | IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.] | 12 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.] | 12 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.] | 12 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA WORLDWIDE, INC.] | 12 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61703-349 | IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.] | 25 | Current NDC, Legacy NDC, 6 package rows | 20250121_5c527c2e-9062-4afe-dbbb-f650db3a340f.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 |
|---|
| 61703-349-09 | 61703034909 | 1 VIAL, SINGLE-DOSE in 1 CARTON (61703-349-09) / 5 mL in 1 VIAL, SINGLE-DOSE | 2008-02-27 | 0000-00-00 | No | No | Current |
| 61703-349-16 | 61703034916 | 1 VIAL, SINGLE-DOSE in 1 CARTON (61703-349-16) / 2 mL in 1 VIAL, SINGLE-DOSE | 2008-02-27 | 0000-00-00 | No | No | Current |
| 61703-349-36 | 61703034936 | 1 VIAL, SINGLE-DOSE in 1 CARTON (61703-349-36) / 25 mL in 1 VIAL, SINGLE-DOSE | 2008-02-27 | 0000-00-00 | No | No | Current |