irinotecan hydrochloide

Generic: irinotecan hydrochloide

Labeler: bluepoint laboratories
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name irinotecan hydrochloide
Generic Name irinotecan hydrochloide
Labeler bluepoint laboratories
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

irinotecan hydrochloride 20 mg/mL

Manufacturer
BluePoint Laboratories

Identifiers & Regulatory

Product NDC 68001-480
Product ID 68001-480_30b09e30-01bd-efc4-e063-6394a90aabc3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212993
Listing Expiration 2026-12-31
Marketing Start 2020-12-14

Pharmacologic Class

Classes
topoisomerase inhibitor [epc] topoisomerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68001480
Hyphenated Format 68001-480

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 hydrochloide (source: ndc)
Generic Name irinotecan hydrochloide (source: ndc)
Application Number ANDA212993 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-480-22) / 5 mL in 1 VIAL, SINGLE-DOSE
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-480-35) / 2 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

68001-480-22 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-480-22) / 5 mL in 1 VIAL, SINGLE-DOSE 68001-480-35 1 VIAL, SINGLE-DOSE in 1 CARTON (68001-480-35) / 2 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

irinotecan hydrochloride (20 mg/mL)

Linked Drug Pages (1)

Irinotecan hydrochloide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "30b09e30-01bd-efc4-e063-6394a90aabc3", "openfda": {"unii": ["042LAQ1IIS"], "rxcui": ["1726319", "1726324"], "spl_set_id": ["b66dbd6d-6ccb-ce9d-e053-2995a90a4c3c"], "manufacturer_name": ["BluePoint Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (68001-480-22)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "68001-480-22", "marketing_start_date": "20201214"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (68001-480-35)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "68001-480-35", "marketing_start_date": "20201214"}], "brand_name": "Irinotecan hydrochloide", "product_id": "68001-480_30b09e30-01bd-efc4-e063-6394a90aabc3", "dosage_form": "INJECTION", "pharm_class": ["Topoisomerase Inhibitor [EPC]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "68001-480", "generic_name": "Irinotecan hydrochloide", "labeler_name": "BluePoint Laboratories", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Irinotecan hydrochloide", "active_ingredients": [{"name": "IRINOTECAN HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA212993", "marketing_category": "ANDA", "marketing_start_date": "20201214", "listing_expiration_date": "20261231"}