NDC product

topcare omeprazole

NDC 36800-601 · Topco Associates LLC

Key facts

Product NDC 36800-601
Proprietary name topcare omeprazole
Nonproprietary name omeprazole
Substances OMEPRAZOLE
Dosage form TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route ORAL
Labeler Topco Associates LLC
Product type HUMAN OTC DRUG
Marketing category NDA
Application number NDA209400
Pharmacologic classes Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
Marketing start Apr 2, 2018
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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