"65162-958-09" National Drug Code (NDC)

Lamotrigine 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-958-09)
(Amneal Pharmaceuticals LLC)

NDC Code65162-958-09
Package Description90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65162-958-09)
Product NDC65162-958
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameLamotrigine
Non-Proprietary NameLamotrigine
Dosage FormTABLET, FILM COATED, EXTENDED RELEASE
UsageORAL
Start Marketing Date20181130
Marketing Category NameANDA
Application NumberANDA207497
ManufacturerAmneal Pharmaceuticals LLC
Substance NameLAMOTRIGINE
Strength100
Strength Unitmg/1
Pharmacy ClassesAnti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE], Dihydrofolate Reductase Inhibitors [MoA], Mood Stabilizer [EPC], Organic Cation Transporter 2 Inhibitors [MoA]

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