NDC product

Isosorbide Mononitrate

NDC 67046-1632 · Coupler LLC

Key facts

Product NDC 67046-1632
Proprietary name Isosorbide Mononitrate
Nonproprietary name Isosorbide Mononitrate
Substances ISOSORBIDE MONONITRATE
Dosage form TABLET, EXTENDED RELEASE
Route ORAL
Labeler Coupler LLC
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA075522
Pharmacologic classes Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
Marketing start Dec 24, 2025
Listing certified through Dec 31, 2026

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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