irinotecan hydrochloride 100 mg/5 ml

Generic: irinotecan hydrochloride

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

Drug Facts

Product Profile

Brand Name irinotecan hydrochloride 100 mg/5 ml
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 72485-212
Product ID 72485-212_e1309129-c950-48ba-b8af-a952d5b3bed3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208718
Listing Expiration 2026-12-31
Marketing Start 2019-04-01

Pharmacologic Class

Classes
topoisomerase inhibitor [epc] topoisomerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72485212
Hyphenated Format 72485-212

Supplemental Identifiers

RxCUI
1726324
UPC
0372485212057
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 100 mg/5 ml (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 in 1 CARTON (72485-212-05) / 5 mL in 1 VIAL
source: ndc

Packages (1)

72485-212-05 1 VIAL in 1 CARTON (72485-212-05) / 5 mL in 1 VIAL

Ingredients (1)

irinotecan hydrochloride (20 mg/mL)

Linked Drug Pages (1)

Irinotecan Hydrochloride 100 mg/5 mL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "e1309129-c950-48ba-b8af-a952d5b3bed3", "openfda": {"upc": ["0372485212057"], "unii": ["042LAQ1IIS"], "rxcui": ["1726324"], "spl_set_id": ["2f160344-4ec6-4285-b293-86c0dd40d8b5"], "manufacturer_name": ["Armas Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (72485-212-05)  / 5 mL in 1 VIAL", "package_ndc": "72485-212-05", "marketing_start_date": "20190401"}], "brand_name": "Irinotecan Hydrochloride 100 mg/5 mL", "product_id": "72485-212_e1309129-c950-48ba-b8af-a952d5b3bed3", "dosage_form": "INJECTION", "pharm_class": ["Topoisomerase Inhibitor [EPC]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "72485-212", "generic_name": "Irinotecan Hydrochloride", "labeler_name": "Armas Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Irinotecan Hydrochloride", "brand_name_suffix": "100 mg/5 mL", "active_ingredients": [{"name": "IRINOTECAN HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA208718", "marketing_category": "ANDA", "marketing_start_date": "20190401", "listing_expiration_date": "20261231"}