irinotecan hydrochloride

Generic: irinotecan hydrochloride

Labeler: ingenus pharmaceuticals, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name irinotecan hydrochloride
Generic Name irinotecan hydrochloride
Labeler ingenus pharmaceuticals, llc
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

irinotecan hydrochloride 40 mg/2mL

Manufacturer
Ingenus Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 50742-401
Product ID 50742-401_3c841594-8a93-4728-b184-0f4bfac73390
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206935
Listing Expiration 2026-12-31
Marketing Start 2017-06-05

Pharmacologic Class

Classes
topoisomerase inhibitor [epc] topoisomerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50742401
Hyphenated Format 50742-401

Supplemental Identifiers

RxCUI
1726319 1726324
UPC
0350742401024 0350742402052
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 ANDA206935 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/2mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (50742-401-02) / 2 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

50742-401-02 1 VIAL, GLASS in 1 CARTON (50742-401-02) / 2 mL in 1 VIAL, GLASS

Ingredients (1)

irinotecan hydrochloride (40 mg/2mL)

Linked Drug Pages (1)

Irinotecan Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "3c841594-8a93-4728-b184-0f4bfac73390", "openfda": {"upc": ["0350742401024", "0350742402052"], "unii": ["042LAQ1IIS"], "rxcui": ["1726319", "1726324"], "spl_set_id": ["d04f2471-3085-4fc8-a657-bb3918d48e6e"], "manufacturer_name": ["Ingenus Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (50742-401-02)  / 2 mL in 1 VIAL, GLASS", "package_ndc": "50742-401-02", "marketing_start_date": "20170605"}], "brand_name": "Irinotecan Hydrochloride", "product_id": "50742-401_3c841594-8a93-4728-b184-0f4bfac73390", "dosage_form": "INJECTION", "pharm_class": ["Topoisomerase Inhibitor [EPC]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "50742-401", "generic_name": "Irinotecan Hydrochloride", "labeler_name": "Ingenus Pharmaceuticals, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Irinotecan Hydrochloride", "active_ingredients": [{"name": "IRINOTECAN HYDROCHLORIDE", "strength": "40 mg/2mL"}], "application_number": "ANDA206935", "marketing_category": "ANDA", "marketing_start_date": "20170605", "listing_expiration_date": "20261231"}