NDC product

topiramate

NDC 65841-647 · Zydus Lifesciences Limited

Key facts

Product NDC 65841-647
Proprietary name topiramate
Nonproprietary name topiramate
Substances TOPIRAMATE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Lifesciences Limited
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA078235
Pharmacologic classes Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]
Marketing start Mar 27, 2009
Listing certified through Dec 31, 2027

At a glance

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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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