onivyde

Generic: irinotecan hydrochloride

Labeler: ipsen biopharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name onivyde
Generic Name irinotecan hydrochloride
Labeler ipsen biopharmaceuticals, inc.
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

irinotecan hydrochloride 4.3 mg/mL

Manufacturer
Ipsen Biopharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 15054-0043
Product ID 15054-0043_72b1786a-3437-4799-8214-f37b5be5607c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA207793
Listing Expiration 2026-12-31
Marketing Start 2015-10-22

Pharmacologic Class

Classes
topoisomerase inhibitor [epc] topoisomerase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 150540043
Hyphenated Format 15054-0043

Supplemental Identifiers

RxCUI
1719772 1719777
UPC
0015054004317
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 onivyde (source: ndc)
Generic Name irinotecan hydrochloride (source: ndc)
Application Number NDA207793 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 4.3 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (15054-0043-1) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

15054-0043-1 1 VIAL, SINGLE-DOSE in 1 CARTON (15054-0043-1) / 10 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

irinotecan hydrochloride (4.3 mg/mL)

Linked Drug Pages (1)

Onivyde ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "72b1786a-3437-4799-8214-f37b5be5607c", "openfda": {"upc": ["0015054004317"], "unii": ["042LAQ1IIS"], "rxcui": ["1719772", "1719777"], "spl_set_id": ["c8b58efa-1820-48a4-b70d-62918fc4abfc"], "manufacturer_name": ["Ipsen Biopharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (15054-0043-1)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "15054-0043-1", "marketing_start_date": "20151022"}], "brand_name": "Onivyde", "product_id": "15054-0043_72b1786a-3437-4799-8214-f37b5be5607c", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Topoisomerase Inhibitor [EPC]", "Topoisomerase Inhibitors [MoA]"], "product_ndc": "15054-0043", "generic_name": "IRINOTECAN HYDROCHLORIDE", "labeler_name": "Ipsen Biopharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Onivyde", "active_ingredients": [{"name": "IRINOTECAN HYDROCHLORIDE", "strength": "4.3 mg/mL"}], "application_number": "NDA207793", "marketing_category": "NDA", "marketing_start_date": "20151022", "listing_expiration_date": "20261231"}