NDC product

Spironolactone and Hydrochlorothiazide

NDC 0378-0403 · Mylan Pharmaceuticals Inc.

Key facts

Product NDC 0378-0403
Proprietary name Spironolactone and Hydrochlorothiazide
Nonproprietary name spironolactone and hydrochlorothiazide
Substances SPIRONOLACTONE, HYDROCHLOROTHIAZIDE
Dosage form TABLET
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA086513
Pharmacologic classes Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
Marketing start Aug 3, 1979
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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