irinotecan hydrochloride

Generic: irinotecan hydrochloride

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name irinotecan hydrochloride
Generic Name irinotecan hydrochloride
Labeler eugia us llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

irinotecan hydrochloride 20 mg/mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-354
Product ID 55150-354_2fc24d11-bf17-4007-8a65-d949793a972e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213278
Listing Expiration 2026-12-31
Marketing Start 2020-02-11

Pharmacologic Class

Classes
topoisomerase inhibitor [epc] topoisomerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150354
Hyphenated Format 55150-354

Supplemental Identifiers

RxCUI
1726319 1726324 1726333
UPC
0355150353019 0355150354016 0355150355013
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 ANDA213278 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-354-01) / 15 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

55150-354-01 1 VIAL, SINGLE-DOSE in 1 CARTON (55150-354-01) / 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": "2fc24d11-bf17-4007-8a65-d949793a972e", "openfda": {"upc": ["0355150353019", "0355150354016", "0355150355013"], "unii": ["042LAQ1IIS"], "rxcui": ["1726319", "1726324", "1726333"], "spl_set_id": ["7a30d551-9ea7-47ea-9073-f541bff457a3"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (55150-354-01)  / 15 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-354-01", "marketing_start_date": "20200211"}], "brand_name": "IRINOTECAN HYDROCHLORIDE", "product_id": "55150-354_2fc24d11-bf17-4007-8a65-d949793a972e", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Topoisomerase Inhibitor [EPC]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "55150-354", "generic_name": "IRINOTECAN HYDROCHLORIDE", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "IRINOTECAN HYDROCHLORIDE", "active_ingredients": [{"name": "IRINOTECAN HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA213278", "marketing_category": "ANDA", "marketing_start_date": "20200211", "listing_expiration_date": "20261231"}