irinotecan hydrochloride

Generic: irinotecan hydrochloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name irinotecan hydrochloride
Generic Name irinotecan hydrochloride
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

irinotecan hydrochloride 20 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9583
Product ID 0143-9583_e36c07c2-a7ad-4d59-bdcc-fe16765b264b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091032
Listing Expiration 2026-12-31
Marketing Start 2010-12-20

Pharmacologic Class

Classes
topoisomerase inhibitor [epc] topoisomerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439583
Hyphenated Format 0143-9583

Supplemental Identifiers

RxCUI
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 ANDA091032 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 5 mL in 1 VIAL, GLASS (0143-9583-01)
source: ndc

Packages (1)

0143-9583-01 5 mL in 1 VIAL, GLASS (0143-9583-01)

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": "e36c07c2-a7ad-4d59-bdcc-fe16765b264b", "openfda": {"unii": ["042LAQ1IIS"], "rxcui": ["1726324"], "spl_set_id": ["9c6aa884-750e-4b11-9955-bc7ab6e9c2ad"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 VIAL, GLASS (0143-9583-01)", "package_ndc": "0143-9583-01", "marketing_start_date": "20101220"}], "brand_name": "Irinotecan Hydrochloride", "product_id": "0143-9583_e36c07c2-a7ad-4d59-bdcc-fe16765b264b", "dosage_form": "INJECTION", "pharm_class": ["Topoisomerase Inhibitor [EPC]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "0143-9583", "generic_name": "Irinotecan Hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Irinotecan Hydrochloride", "active_ingredients": [{"name": "IRINOTECAN HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA091032", "marketing_category": "ANDA", "marketing_start_date": "20101220", "listing_expiration_date": "20261231"}