irinotecan hydrochloride

Generic: irinotecan hydrochloride

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name irinotecan hydrochloride
Generic Name irinotecan hydrochloride
Labeler actavis pharma, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

irinotecan hydrochloride 20 mg/mL

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 45963-614
Product ID 45963-614_8f2da07f-1d3e-4d8b-8083-805da8a780db
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078589
Listing Expiration 2026-12-31
Marketing Start 2015-03-12

Pharmacologic Class

Classes
topoisomerase inhibitor [epc] topoisomerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45963614
Hyphenated Format 45963-614

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 ANDA078589 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-614-51) / 2 mL in 1 VIAL, SINGLE-DOSE
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-614-55) / 5 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

45963-614-51 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-614-51) / 2 mL in 1 VIAL, SINGLE-DOSE 45963-614-55 1 VIAL, SINGLE-DOSE in 1 CARTON (45963-614-55) / 5 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": "8f2da07f-1d3e-4d8b-8083-805da8a780db", "openfda": {"unii": ["042LAQ1IIS"], "rxcui": ["1726319", "1726324"], "spl_set_id": ["5e1fdcaa-918f-4cd8-9c7a-4c538d866198"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (45963-614-51)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "45963-614-51", "marketing_start_date": "20150312"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (45963-614-55)  / 5 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "45963-614-55", "marketing_start_date": "20150312"}], "brand_name": "Irinotecan hydrochloride", "product_id": "45963-614_8f2da07f-1d3e-4d8b-8083-805da8a780db", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Topoisomerase Inhibitor [EPC]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "45963-614", "generic_name": "Irinotecan hydrochloride", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Irinotecan hydrochloride", "active_ingredients": [{"name": "IRINOTECAN HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA078589", "marketing_category": "ANDA", "marketing_start_date": "20150312", "listing_expiration_date": "20261231"}