Irinotecan Hydrochloride
- Product NDC
- 72485-213
- 11-digit product format
- 724850213
- Labeler code
- 72485
- Product ID
- 72485-213_16bc41f7-c83f-473e-bf17-9e6328cecb4b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irinotecan Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Armas Pharmaceuticals Inc.
- Application
- ANDA208718
- Marketing category
- ANDA
- Marketing start
- 2020-09-04
- 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 | 1726333 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72485-213-15 | Irinotecan Hydrochloride | 1 in 1 CARTON | INJECTION | 1 | | 1 |
| 72485-213-15 | Irinotecan Hydrochloride | 15 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 15 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72485-213 | IRINOTECAN HYDROCHLORIDE INJECTION [ARMAS PHARMACEUTICALS INC.] | 1 | Current NDC, Legacy NDC, 2 package rows | 20200908_6a186e60-6ea1-4450-9668-dac7dd7a03e3.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 |
|---|
| 72485-213-15 | 72485021315 | 1 VIAL, SINGLE-DOSE in 1 CARTON (72485-213-15) / 15 mL in 1 VIAL, SINGLE-DOSE | 2020-09-04 | 0000-00-00 | No | No | Current |