NDC product

MONTELUKAST SODIUM

NDC 16571-100 · Rising Pharma Holdings, Inc.

Key facts

Product NDC 16571-100
Proprietary name MONTELUKAST SODIUM
Nonproprietary name MONTELUKAST SODIUM
Substances MONTELUKAST SODIUM
Dosage form TABLET
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA209012
Pharmacologic classes Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]
Marketing start Jun 1, 2023
Listing certified through Dec 31, 2026

At a glance

  • 1–9 Package NDCs

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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:

Browse all National Drug Codes (NDC)