NDC product

Macitentan

NDC 59651-147 · Aurobindo Pharma Limited

Key facts

Product NDC 59651-147
Proprietary name Macitentan
Nonproprietary name Macitentan
Substances MACITENTAN
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA211198
Pharmacologic classes Endothelin Receptor Antagonist [EPC], Endothelin Receptor Antagonists [MoA]
Marketing start Jun 8, 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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