"68382-979-05" National Drug Code (NDC)

Lamotrigine 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-979-05)
(Zydus Pharmaceuticals USA Inc.)

NDC Code68382-979-05
Package Description500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-979-05)
Product NDC68382-979
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameLamotrigine
Non-Proprietary NameLamotrigine
Dosage FormTABLET, EXTENDED RELEASE
UsageORAL
Start Marketing Date20200514
Marketing Category NameANDA
Application NumberANDA207763
ManufacturerZydus Pharmaceuticals USA Inc.
Substance NameLAMOTRIGINE
Strength25
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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