Irinotecan Hydrochloride
- Product NDC
- 63323-193
- 11-digit product format
- 633230193
- Labeler code
- 63323
- Product ID
- 63323-193_4e0a18c8-35aa-447c-bd91-b81d7d494d8e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- IRINOTECAN HYDROCHLORIDE
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Fresenius Kabi USA, LLC
- Application
- ANDA077776
- Marketing category
- ANDA
- Marketing start
- 2009-04-01
- 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
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63323-193-52 | Irinotecan Hydrochloride | 1 in 1 BOX | INJECTION, SOLUTION | 1 | | 7 |
| 63323-193-52 | Irinotecan Hydrochloride | 2 mL in 1 VIAL | INJECTION, SOLUTION | 2 | | 7 |
| 63323-193-55 | Irinotecan Hydrochloride | 1 in 1 BOX | INJECTION, SOLUTION | 1 | | 7 |
| 63323-193-55 | Irinotecan Hydrochloride | 5 mL in 1 VIAL | INJECTION, SOLUTION | 5 | | 7 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| IRINOTECAN HYDROCHLORIDE | ACTIVE INGREDIENT | 042LAQ1IIS | IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| IRINOTECAN | ACTIVE MOIETY | 7673326042 | IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| LACTIC ACID | INACTIVE INGREDIENT | 33X04XA5AT | IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63323-193 | IRINOTECAN HYDROCHLORIDE INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] | 7 | Current NDC, Legacy NDC, 4 package rows | 20230412_ee45f127-8450-4455-a945-a1f5707f1d39.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 |
|---|
| 63323-193-52 | 63323019352 | 1 VIAL in 1 BOX (63323-193-52) / 2 mL in 1 VIAL | 1 vial | 2009-04-01 | 0000-00-00 | No | No | Current |
| 63323-193-55 | 63323019355 | 1 VIAL in 1 BOX (63323-193-55) / 5 mL in 1 VIAL | 1 vial | 2009-04-01 | 0000-00-00 | No | No | Current |