Irinotecan Hydrochloride
- Product NDC
- 72485-211
- 11-digit product format
- 724850211
- Labeler code
- 72485
- Product ID
- 72485-211_2c48b1cc-14b4-4de2-9cea-58a89cf32147
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irinotecan Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Armas Pharmaceuticals Inc.
- Application
- ANDA208718
- Marketing category
- ANDA
- Marketing start
- 2019-04-01
- 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
- Brand name suffix
- 40 mg/2 mL
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72485-211-02 | Irinotecan Hydrochloride40 mg/2 mL | 2 mL in 1 VIAL | INJECTION | 2 | | 2 |
| 72485-211-02 | Irinotecan Hydrochloride40 mg/2 mL | 1 in 1 CARTON | INJECTION | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72485-211 | IRINOTECAN HYDROCHLORIDE 40 MG/2 ML (IRINOTECAN HYDROCHLORIDE) INJECTION [ARMAS PHARMACEUTICALS INC.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20200908_828932fc-8923-4874-9131-980d5d2a2c86.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 |
|---|
| 72485-211-02 | 72485021102 | 1 VIAL in 1 CARTON (72485-211-02) / 2 mL in 1 VIAL | 1 vial | 2019-04-01 | 0000-00-00 | No | No | Current |