NDC product

Lamotrigine Extended-Release

NDC 10370-256 · Par Health USA, LLC

Key facts

Product NDC 10370-256
Proprietary name Lamotrigine
Nonproprietary name lamotrigine
Substances LAMOTRIGINE
Dosage form TABLET, FILM COATED, EXTENDED RELEASE
Route ORAL
Labeler Par Health USA, LLC
Product type HUMAN PRESCRIPTION DRUG
Marketing category ANDA
Application number ANDA201374
Pharmacologic classes Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]
Marketing start Jan 2, 2026
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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