camptosar

Generic: irinotecan hydrochloride

Labeler: pharmacia & upjohn company llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name camptosar
Generic Name irinotecan hydrochloride
Labeler pharmacia & upjohn company llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

irinotecan hydrochloride 20 mg/mL

Manufacturer
Pharmacia & Upjohn Company LLC

Identifiers & Regulatory

Product NDC 0009-0082
Product ID 0009-0082_749c4a75-bd68-4e5e-bf2d-d82d254e3fc6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020571
Listing Expiration 2026-12-31
Marketing Start 2024-06-24

Pharmacologic Class

Classes
topoisomerase inhibitor [epc] topoisomerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00090082
Hyphenated Format 0009-0082

Supplemental Identifiers

RxCUI
1726319 1726321 1726324 1726325 1726333 1726335
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 camptosar (source: ndc)
Generic Name irinotecan hydrochloride (source: ndc)
Application Number NDA020571 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (0009-0082-02) / 15 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0009-0082-02 1 VIAL, SINGLE-DOSE in 1 CARTON (0009-0082-02) / 15 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

irinotecan hydrochloride (20 mg/mL)

Linked Drug Pages (1)

Camptosar ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "749c4a75-bd68-4e5e-bf2d-d82d254e3fc6", "openfda": {"unii": ["042LAQ1IIS"], "rxcui": ["1726319", "1726321", "1726324", "1726325", "1726333", "1726335"], "spl_set_id": ["e518dfc6-7e93-4fee-a66c-51e1ab71c056"], "manufacturer_name": ["Pharmacia & Upjohn Company LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (0009-0082-02)  / 15 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0009-0082-02", "marketing_start_date": "20240624"}], "brand_name": "Camptosar", "product_id": "0009-0082_749c4a75-bd68-4e5e-bf2d-d82d254e3fc6", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Topoisomerase Inhibitor [EPC]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "0009-0082", "generic_name": "irinotecan hydrochloride", "labeler_name": "Pharmacia & Upjohn Company LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Camptosar", "active_ingredients": [{"name": "IRINOTECAN HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "NDA020571", "marketing_category": "NDA", "marketing_start_date": "20240624", "listing_expiration_date": "20261231"}