NDC product

DILANTIN

NDC 58151-110 · Viatris Specialty LLC

Key facts

Product NDC 58151-110
Proprietary name DILANTIN
Nonproprietary name Extended Phenytoin Sodium
Substances PHENYTOIN SODIUM
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Viatris Specialty LLC
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA084349
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 6, 2024
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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