Irinotecan Hydrochloride
- Product NDC
- 59923-702
- 11-digit product format
- 599230702
- Labeler code
- 59923
- Product ID
- 59923-702_861da8ed-500e-4495-e053-2a91aa0ac4d1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Irinotecan Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Areva Pharmaceuticals,Inc.
- Application
- ANDA077219
- Marketing category
- ANDA
- Marketing start
- 2008-02-20
- Marketing end
- 0000-00-00
- Substance
- IRINOTECAN HYDROCHLORIDE
- Active strength
- 20 mg/mL
- Pharmacologic classes
- Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 59923-702-02 | 2025-12-30 | C162847 | 48780-1 | 1030e365-2fde-111a-e063-dadaa90a10e2 | 80f3b79c-a399-45b3-b755-8535457719af |
| 59923-702-05 | 2025-12-30 | C162847 | 48780-1 | 1030e365-2fde-111a-e063-dadaa90a10e2 | 80f3b79c-a399-45b3-b755-8535457719af |
| 59923-702-02 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2fde-111a-e063-dadaa90a10e2 | 80f3b79c-a399-45b3-b755-8535457719af |
| 59923-702-05 | 2024-01-30 | C162847 | 48780-1 | 1030e365-2fde-111a-e063-dadaa90a10e2 | 80f3b79c-a399-45b3-b755-8535457719af |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59923-702-02 | ML - Milliliter | 59923-702 | 50369e8d-66b9-43ea-b34b-77d6e3c37ad7 | 1 | 2013-07-02 |
| 59923-702-05 | ML - Milliliter | 59923-702 | 775943a3-8343-408d-9d48-0b519e40087f | 1 | 2013-07-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| IRINOTECAN HYDROCHLORIDE | ACTIVE INGREDIENT | 042LAQ1IIS | IRINOTECAN HYDROCHLORIDE (IRINOTECAN) INJECTION [AREVA PHARMACEUTICALS,INC.] | 1 | |
| IRINOTECAN | ACTIVE MOIETY | 7673326042 | IRINOTECAN HYDROCHLORIDE (IRINOTECAN) INJECTION [AREVA PHARMACEUTICALS,INC.] | 1 | |
| LACTIC ACID | INACTIVE INGREDIENT | 33X04XA5AT | IRINOTECAN HYDROCHLORIDE (IRINOTECAN) INJECTION [AREVA PHARMACEUTICALS,INC.] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | IRINOTECAN HYDROCHLORIDE (IRINOTECAN) INJECTION [AREVA PHARMACEUTICALS,INC.] | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | IRINOTECAN HYDROCHLORIDE (IRINOTECAN) INJECTION [AREVA PHARMACEUTICALS,INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | IRINOTECAN HYDROCHLORIDE (IRINOTECAN) INJECTION [AREVA PHARMACEUTICALS,INC.] | 1 |
DailyMed Dashboard NDC Coverage#
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 59923-702-02 | 59923070202 | 1 VIAL in 1 CARTON (59923-702-02) > 2 mL in 1 VIAL | 1 vial | 2008-02-20 | 0000-00-00 | No | No | Current |
| 59923-702-05 | 59923070205 | 1 VIAL in 1 CARTON (59923-702-05) > 5 mL in 1 VIAL | 1 vial | 2008-02-20 | 0000-00-00 | No | No | Current |