irinotecan hydrochloride

Generic: irinotecan hydrochloride

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name irinotecan hydrochloride
Generic Name irinotecan hydrochloride
Labeler sagent pharmaceuticals
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

irinotecan hydrochloride 20 mg/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-230
Product ID 25021-230_beff4b0b-e884-4134-ba9e-290020a94add
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090675
Marketing Start 2014-08-15
Marketing End 2026-10-31

Pharmacologic Class

Classes
topoisomerase inhibitor [epc] topoisomerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25021230
Hyphenated Format 25021-230

Supplemental Identifiers

RxCUI
1726319 1726324
UNII
042LAQ1IIS

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name irinotecan hydrochloride (source: ndc)
Generic Name irinotecan hydrochloride (source: ndc)
Application Number ANDA090675 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (25021-230-02) / 2 mL in 1 VIAL
  • 1 VIAL in 1 CARTON (25021-230-05) / 5 mL in 1 VIAL
source: ndc

Packages (2)

25021-230-02 1 VIAL in 1 CARTON (25021-230-02) / 2 mL in 1 VIAL 25021-230-05 1 VIAL in 1 CARTON (25021-230-05) / 5 mL in 1 VIAL

Ingredients (1)

irinotecan hydrochloride (20 mg/mL)

Linked Drug Pages (1)

Irinotecan Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "beff4b0b-e884-4134-ba9e-290020a94add", "openfda": {"unii": ["042LAQ1IIS"], "rxcui": ["1726319", "1726324"], "spl_set_id": ["caab50e6-0dad-4ddd-9a6c-96cc2b87aee7"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (25021-230-02)  / 2 mL in 1 VIAL", "package_ndc": "25021-230-02", "marketing_end_date": "20261031", "marketing_start_date": "20140815"}, {"sample": false, "description": "1 VIAL in 1 CARTON (25021-230-05)  / 5 mL in 1 VIAL", "package_ndc": "25021-230-05", "marketing_end_date": "20260831", "marketing_start_date": "20140815"}], "brand_name": "Irinotecan Hydrochloride", "product_id": "25021-230_beff4b0b-e884-4134-ba9e-290020a94add", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Topoisomerase Inhibitor [EPC]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "25021-230", "generic_name": "irinotecan hydrochloride", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Irinotecan Hydrochloride", "active_ingredients": [{"name": "IRINOTECAN HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA090675", "marketing_category": "ANDA", "marketing_end_date": "20261031", "marketing_start_date": "20140815"}