irinotecan hydrochloride

Generic: irinotecan hydrochloride

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name irinotecan hydrochloride
Generic Name irinotecan hydrochloride
Labeler apotex corp.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

irinotecan hydrochloride 20 mg/mL

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-6128
Product ID 60505-6128_d2676b1a-30fb-456b-bb51-fb76fb64cf2d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203380
Listing Expiration 2026-12-31
Marketing Start 2017-11-30

Pharmacologic Class

Classes
topoisomerase inhibitor [epc] topoisomerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605056128
Hyphenated Format 60505-6128

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 ANDA203380 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (60505-6128-0) / 2 mL in 1 VIAL, SINGLE-USE
  • 1 VIAL, SINGLE-USE in 1 CARTON (60505-6128-1) / 5 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (2)

60505-6128-0 1 VIAL, SINGLE-USE in 1 CARTON (60505-6128-0) / 2 mL in 1 VIAL, SINGLE-USE 60505-6128-1 1 VIAL, SINGLE-USE in 1 CARTON (60505-6128-1) / 5 mL in 1 VIAL, SINGLE-USE

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": "d2676b1a-30fb-456b-bb51-fb76fb64cf2d", "openfda": {"unii": ["042LAQ1IIS"], "rxcui": ["1726319", "1726324"], "spl_set_id": ["85ed6019-f462-4abe-a89e-ad991623c86d"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (60505-6128-0)  / 2 mL in 1 VIAL, SINGLE-USE", "package_ndc": "60505-6128-0", "marketing_start_date": "20171130"}, {"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (60505-6128-1)  / 5 mL in 1 VIAL, SINGLE-USE", "package_ndc": "60505-6128-1", "marketing_start_date": "20171130"}], "brand_name": "Irinotecan Hydrochloride", "product_id": "60505-6128_d2676b1a-30fb-456b-bb51-fb76fb64cf2d", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Topoisomerase Inhibitor [EPC]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "60505-6128", "generic_name": "Irinotecan Hydrochloride", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Irinotecan Hydrochloride", "active_ingredients": [{"name": "IRINOTECAN HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA203380", "marketing_category": "ANDA", "marketing_start_date": "20171130", "listing_expiration_date": "20261231"}