NDC product

MONTELUKAST SODIUM

NDC 70518-4753 · REMEDYREPACK INC.

Key facts

Product NDC 70518-4753
Proprietary name MONTELUKAST SODIUM
Nonproprietary name MONTELUKAST SODIUM
Substances MONTELUKAST SODIUM
Dosage form TABLET
Route ORAL
Labeler REMEDYREPACK INC.
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA209012
Pharmacologic classes Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]
Marketing start Sep 14, 2026
Listing certified through Dec 31, 2027

At a glance

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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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