NDC product

MONTELUKAST SODIUM

NDC 72189-223 · DIRECT RX

Key facts

Product NDC 72189-223
Proprietary name MONTELUKAST SODIUM
Nonproprietary name MONTELUKAST SODIUM
Substances MONTELUKAST
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler DIRECT RX
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA204093
Pharmacologic classes Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]
Marketing start May 21, 2021
Listing certified through Dec 31, 2026

At a glance

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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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