NDC product

Mesalamine

NDC 21922-045 · Encube Ethicals, Inc.

Key facts

Product NDC 21922-045
Proprietary name Mesalamine
Nonproprietary name Mesalamine
Substances MESALAMINE
Dosage form SUSPENSION
Route RECTAL
Labeler Encube Ethicals, Inc.
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA216941
Pharmacologic classes Aminosalicylate [EPC], Aminosalicylic Acids [CS]
Marketing start Jun 1, 2023
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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