NDC product

Macitentan

NDC 13668-542 · Torrent Pharmaceuticals Limited

Key facts

Product NDC 13668-542
Proprietary name Macitentan
Nonproprietary name Macitentan
Substances MACITENTAN
Dosage form TABLET
Route ORAL
Labeler Torrent Pharmaceuticals Limited
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA211107
Pharmacologic classes Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
Marketing start Jun 1, 2026
Listing certified through Dec 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 · Source date:

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