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NDC 63323-0193-52 Irinotecan Hydrochloride 20 mg/mL Details
Irinotecan Hydrochloride 20 mg/mL
Irinotecan Hydrochloride is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is IRINOTECAN HYDROCHLORIDE.
MedlinePlus Drug Summary
Irinotecan is used alone or in combination with other medications to treat colon or rectal cancer (cancer that begins in the large intestine). Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It works by stopping the growth of cancer cells.
Related Packages: 63323-0193-52Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Irinotecan Injection
Product Information
| NDC | 63323-0193 |
|---|---|
| Product ID | 63323-193_4e0a18c8-35aa-447c-bd91-b81d7d494d8e |
| Associated GPIs | 21550040102025 21550040102030 |
| GCN Sequence Number | 062173 |
| GCN Sequence Number Description | irinotecan HCl VIAL 40 MG/2 ML INTRAVEN |
| HIC3 | V3E |
| HIC3 Description | ANTINEOPLASTIC - TOPOISOMERASE I INHIBITORS |
| GCN | 97955 |
| HICL Sequence Number | 010778 |
| HICL Sequence Number Description | IRINOTECAN HCL |
| Brand/Generic | Generic |
| Proprietary Name | Irinotecan Hydrochloride |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | IRINOTECAN HYDROCHLORIDE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 20 |
| Active Ingredient Units | mg/mL |
| Substance Name | IRINOTECAN HYDROCHLORIDE |
| Labeler Name | Fresenius Kabi USA, LLC |
| Pharmaceutical Class | Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA077776 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63323-0193-52 (63323019352)
| NDC Package Code | 63323-193-52 |
|---|---|
| Billing NDC | 63323019352 |
| Package | 1 VIAL in 1 BOX (63323-193-52) / 2 mL in 1 VIAL |
| Marketing Start Date | 2009-04-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |