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.
| Product ID | 63323-193_77d71b99-b25c-47df-bdea-f7a04d132b64 |
| NDC | 63323-193 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Irinotecan Hydrochloride |
| Generic Name | Irinotecan Hydrochloride |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2009-04-01 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA078188 |
| Labeler Name | Fresenius Kabi USA, LLC |
| Substance Name | IRINOTECAN HYDROCHLORIDE |
| Active Ingredient Strength | 20 mg/mL |
| Pharm Classes | Topoisomerase Inhibitor [EPC],Topoisomerase Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
| Marketing Start Date | 2009-04-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA077776 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2009-04-01 |
| Marketing Category | ANDA |
| Application Number | ANDA077776 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2009-04-01 |
| Marketing Category | ANDA |
| Application Number | ANDA078188 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2009-04-01 |
| Marketing End Date | 2015-04-30 |
| Marketing Category | ANDA |
| Application Number | ANDA078188 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2009-04-01 |
| Marketing End Date | 2015-05-31 |
| Ingredient | Strength |
|---|---|
| IRINOTECAN HYDROCHLORIDE | 20 mg/mL |
| SPL SET ID: | 2361c88c-124e-4f6c-aef2-c70612f0eb64 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0143-9583 | Irinotecan Hydrochloride | Irinotecan Hydrochloride |
| 0143-9701 | Irinotecan Hydrochloride | Irinotecan Hydrochloride |
| 0143-9702 | Irinotecan Hydrochloride | Irinotecan Hydrochloride |
| 0703-4432 | Irinotecan Hydrochloride | Irinotecan Hydrochloride |
| 0703-4434 | Irinotecan Hydrochloride | Irinotecan Hydrochloride |
| 16714-027 | Irinotecan hydrochloride | Irinotecan hydrochloride |
| 16714-131 | Irinotecan hydrochloride | Irinotecan hydrochloride |
| 16714-725 | Irinotecan Hydrochloride | Irinotecan Hydrochloride |
| 16714-726 | Irinotecan Hydrochloride | Irinotecan Hydrochloride |
| 23155-179 | Irinotecan Hydrochloride | Irinotecan Hydrochloride |
| 25021-230 | Irinotecan Hydrochloride | irinotecan hydrochloride |
| 45963-614 | Irinotecan hydrochloride | Irinotecan hydrochloride |
| 50742-401 | Irinotecan Hydrochloride | Irinotecan Hydrochloride |
| 68001-284 | Irinotecan Hydrochloride | Irinotecan Hydrochloride |
| 50742-402 | Irinotecan Hydrochloride | Irinotecan Hydrochloride |
| 59923-714 | Irinotecan Hydrochloride | Irinotecan Hydrochloride |
| 59923-702 | Irinotecan Hydrochloride | Irinotecan Hydrochloride |
| 60505-6128 | Irinotecan Hydrochloride | Irinotecan Hydrochloride |
| 59923-715 | Irinotecan Hydrochloride | Irinotecan Hydrochloride |
| 61703-349 | Irinotecan Hydrochloride | Irinotecan Hydrochloride |
| 63323-193 | Irinotecan Hydrochloride | Irinotecan Hydrochloride |
| 67184-0513 | Irinotecan Hydrochloride | Irinotecan Hydrochloride |
| 67184-0512 | Irinotecan Hydrochloride | Irinotecan Hydrochloride |
| 67184-0511 | Irinotecan Hydrochloride | Irinotecan Hydrochloride |
| 68083-382 | Irinotecan hydrochloride | Irinotecan hydrochloride |
| 59923-716 | Irinotecan Hydrochloride | Irinotecan Hydrochloride |
| 0009-1111 | Camptosar | irinotecan hydrochloride |
| 0009-7529 | Camptosar | irinotecan hydrochloride |
| 15054-0043 | Onivyde | IRINOTECAN HYDROCHLORIDE |