irinotecan hydrochloride

Generic: irinotecan hydrochloride

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

Drug Facts

Product Profile

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

irinotecan hydrochloride 20 mg/mL

Manufacturer
Armas Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 72485-213
Product ID 72485-213_16bc41f7-c83f-473e-bf17-9e6328cecb4b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208718
Listing Expiration 2026-12-31
Marketing Start 2020-09-04

Pharmacologic Class

Classes
topoisomerase inhibitor [epc] topoisomerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72485213
Hyphenated Format 72485-213

Supplemental Identifiers

RxCUI
1726333
UPC
0372485213153
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 ANDA208718 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (72485-213-15) / 15 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

72485-213-15 1 VIAL, SINGLE-DOSE in 1 CARTON (72485-213-15) / 15 mL in 1 VIAL, SINGLE-DOSE

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": "16bc41f7-c83f-473e-bf17-9e6328cecb4b", "openfda": {"upc": ["0372485213153"], "unii": ["042LAQ1IIS"], "rxcui": ["1726333"], "spl_set_id": ["6a186e60-6ea1-4450-9668-dac7dd7a03e3"], "manufacturer_name": ["Armas Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (72485-213-15)  / 15 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "72485-213-15", "marketing_start_date": "20200904"}], "brand_name": "Irinotecan Hydrochloride", "product_id": "72485-213_16bc41f7-c83f-473e-bf17-9e6328cecb4b", "dosage_form": "INJECTION", "pharm_class": ["Topoisomerase Inhibitor [EPC]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "72485-213", "generic_name": "Irinotecan Hydrochloride", "labeler_name": "Armas Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Irinotecan Hydrochloride", "active_ingredients": [{"name": "IRINOTECAN HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA208718", "marketing_category": "ANDA", "marketing_start_date": "20200904", "listing_expiration_date": "20261231"}