IRINOTECAN HYDROCHLORIDE
- Product NDC
- 55150-355
- 11-digit product format
- 551500355
- Labeler code
- 55150
- Product ID
- 55150-355_2fc24d11-bf17-4007-8a65-d949793a972e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- IRINOTECAN HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Eugia US LLC
- Application
- ANDA213278
- Marketing category
- ANDA
- Marketing start
- 2022-04-11
- 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 |
|---|
| 55150-355-01 | IRINOTECAN HYDROCHLORIDE | 25 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 25 | | 4 |
| 55150-355-01 | IRINOTECAN HYDROCHLORIDE | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-355 | IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [EUGIA US LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20230731_7a30d551-9ea7-47ea-9073-f541bff457a3.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 |
|---|
| 55150-355-01 | 55150035501 | 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-355-01) / 25 mL in 1 VIAL, SINGLE-DOSE | 2022-04-11 | 0000-00-00 | No | No | Current |