NDC product

SPIRONOLACTONE

NDC 53489-328 · Sun Pharmaceutical Industries, Inc.

Key facts

Product NDC 53489-328
Proprietary name SPIRONOLACTONE
Nonproprietary name SPIRONOLACTONE
Substances SPIRONOLACTONE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sun Pharmaceutical Industries, Inc.
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA089424
Pharmacologic classes Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA]
Marketing start Jul 23, 1986
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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