NDC product

Extended Phenytoin Sodium

NDC 65162-212 · Amneal Pharmaceuticals LLC

Key facts

Product NDC 65162-212
Proprietary name Extended Phenytoin Sodium
Nonproprietary name Phenytoin Sodium
Substances PHENYTOIN SODIUM
Dosage form CAPSULE
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA040765
Pharmacologic classes Anti-epileptic Agent [EPC], Cytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA] and 3 more
Marketing start Dec 16, 2009
Listing certified through Dec 31, 2027

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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