NDC product

AZELEX

NDC 16110-869 · Almirall, LLC

Key facts

Product NDC 16110-869
Proprietary name AZELEX
Nonproprietary name azelaic acid
Substances AZELAIC ACID
Dosage form CREAM
Route CUTANEOUS
Labeler Almirall, LLC
Product type HUMAN PRESCRIPTION DRUG
Marketing category NDA
Application number NDA020428
Pharmacologic classes Decreased Protein Synthesis [PE], Decreased Sebaceous Gland Activity [PE]
Marketing start Sep 24, 2018
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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