NDC product

Omeprazole

NDC 80425-0504 · Advanced Rx of Tennessee, LLC

Key facts

Product NDC 80425-0504
Proprietary name Omeprazole
Nonproprietary name Omeprazole
Substances OMEPRAZOLE
Dosage form CAPSULE, DELAYED RELEASE
Route ORAL
Labeler Advanced Rx of Tennessee, LLC
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA078490
Pharmacologic classes Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
Marketing start Mar 6, 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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