NDC product

Mesalamine

NDC 0378-1375 · Mylan Pharmaceuticals Inc.

Key facts

Product NDC 0378-1375
Proprietary name Mesalamine
Nonproprietary name mesalamine
Substances MESALAMINE
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA207271
Pharmacologic classes Aminosalicylate [EPC], Aminosalicylic Acids [CS]
Marketing start Nov 26, 2019
Marketing end Jul 31, 2027

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

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