NDC product

Onivyde

NDC 15054-0043 · Ipsen Biopharmaceuticals, Inc.

Key facts

Product NDC 15054-0043
Proprietary name Onivyde
Nonproprietary name IRINOTECAN HYDROCHLORIDE
Substances IRINOTECAN HYDROCHLORIDE
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Ipsen Biopharmaceuticals, Inc.
Product type HUMAN PRESCRIPTION DRUG
Marketing category NDA
Application number NDA207793
Pharmacologic classes Topoisomerase Inhibitor [EPC], Topoisomerase Inhibitors [MoA]
Marketing start Oct 22, 2015
Listing certified through Dec 31, 2026

At a glance

  • 1–9 Package NDCs

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About National Drug Codes (NDC)

The National Drug Code (NDC) is the FDA's product identifier for drugs; the product NDC identifies the labeler and product, and each package adds a package code.

Source: U.S. Food and Drug Administration (FDA), National Drug Code Directory · Source date:

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