NDC product

topcare esomeprazole magnesium

NDC 36800-627 · Topco Associates LLC

Key facts

Product NDC 36800-627
Proprietary name topcare esomeprazole magnesium
Nonproprietary name esomeprazole magnesium
Substances ESOMEPRAZOLE MAGNESIUM DIHYDRATE
Dosage form CAPSULE, DELAYED RELEASE
Route ORAL
Labeler Topco Associates LLC
Product type HUMAN OTC DRUG
Marketing category ANDA
Application number ANDA207193
Pharmacologic classes Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
Marketing start Mar 12, 2020
Listing certified through Dec 31, 2026

At a glance

  • 1–9 Package NDCs

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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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