Irinotecan Hydrochloride
- Product NDC
- 67184-0511
- 11-digit product format
- 671840511
- Labeler code
- 67184
- Product ID
- 67184-0511_5faaf9ca-ed20-4ebf-9e7f-1d3a0ca60056
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irinotecan Hydrochloride
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Qilu Pharmaceutical Co., Ltd.
- Application
- ANDA203380
- Marketing category
- ANDA
- Marketing start
- 2016-05-03
- 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, 1726333 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 67184-0511-1 | Irinotecan Hydrochloride | 2 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION | 2 | | 5 |
| 67184-0511-1 | Irinotecan Hydrochloride | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67184-0511 | IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [QILU PHARMACEUTICAL CO., LTD.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20210311_afcdde49-ec0c-4c56-a1af-2917185b1a08.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 |
|---|
| 67184-0511-1 | 67184051101 | 1 VIAL, SINGLE-USE in 1 CARTON (67184-0511-1) / 2 mL in 1 VIAL, SINGLE-USE | 2016-05-03 | 0000-00-00 | No | No | Current |