irinotecan hydrochloride

Generic: irinotecan hydrochloride

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name irinotecan hydrochloride
Generic Name irinotecan hydrochloride
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

irinotecan hydrochloride 20 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-193
Product ID 63323-193_4e0a18c8-35aa-447c-bd91-b81d7d494d8e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077776
Listing Expiration 2026-12-31
Marketing Start 2009-04-01

Pharmacologic Class

Classes
topoisomerase inhibitor [epc] topoisomerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323193
Hyphenated Format 63323-193

Supplemental Identifiers

RxCUI
1726319 1726324
UPC
0363323193522 0363323193553
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 ANDA077776 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 VIAL in 1 BOX (63323-193-52) / 2 mL in 1 VIAL
  • 1 VIAL in 1 BOX (63323-193-55) / 5 mL in 1 VIAL
source: ndc

Packages (2)

63323-193-52 1 VIAL in 1 BOX (63323-193-52) / 2 mL in 1 VIAL 63323-193-55 1 VIAL in 1 BOX (63323-193-55) / 5 mL in 1 VIAL

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": "4e0a18c8-35aa-447c-bd91-b81d7d494d8e", "openfda": {"upc": ["0363323193522", "0363323193553"], "unii": ["042LAQ1IIS"], "rxcui": ["1726319", "1726324"], "spl_set_id": ["ee45f127-8450-4455-a945-a1f5707f1d39"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 BOX (63323-193-52)  / 2 mL in 1 VIAL", "package_ndc": "63323-193-52", "marketing_start_date": "20090401"}, {"sample": false, "description": "1 VIAL in 1 BOX (63323-193-55)  / 5 mL in 1 VIAL", "package_ndc": "63323-193-55", "marketing_start_date": "20090401"}], "brand_name": "Irinotecan Hydrochloride", "product_id": "63323-193_4e0a18c8-35aa-447c-bd91-b81d7d494d8e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Topoisomerase Inhibitor [EPC]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "63323-193", "generic_name": "IRINOTECAN HYDROCHLORIDE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Irinotecan Hydrochloride", "active_ingredients": [{"name": "IRINOTECAN HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA077776", "marketing_category": "ANDA", "marketing_start_date": "20090401", "listing_expiration_date": "20261231"}