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NDC 68001-0480-22 Irinotecan hydrochloide 20 mg/mL Details
Irinotecan hydrochloide 20 mg/mL
Irinotecan hydrochloide is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by BluePoint Laboratories. 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: 68001-0480-22Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Irinotecan Injection
Product Information
| NDC | 68001-0480 |
|---|---|
| Product ID | 68001-480_0904e574-8e86-f26a-e063-6394a90afc0b |
| Associated GPIs | 21550040102030 21550040102025 |
| GCN Sequence Number | 062174 |
| GCN Sequence Number Description | irinotecan HCl VIAL 100 MG/5ML INTRAVEN |
| HIC3 | V3E |
| HIC3 Description | ANTINEOPLASTIC - TOPOISOMERASE I INHIBITORS |
| GCN | 97956 |
| HICL Sequence Number | 010778 |
| HICL Sequence Number Description | IRINOTECAN HCL |
| Brand/Generic | Generic |
| Proprietary Name | Irinotecan hydrochloide |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Irinotecan hydrochloide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 20 |
| Active Ingredient Units | mg/mL |
| Substance Name | IRINOTECAN HYDROCHLORIDE |
| Labeler Name | BluePoint Laboratories |
| Pharmaceutical Class | Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA212993 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 68001-0480-22 (68001048022)
| NDC Package Code | 68001-480-22 |
|---|---|
| Billing NDC | 68001048022 |
| Package | 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-480-22) / 5 mL in 1 VIAL, SINGLE-DOSE |
| Marketing Start Date | 2020-12-14 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |