{"effective_time":"20241130","id":"c2007dd5-98b7-47e2-8354-7ce432174a48","openfda":{"application_number":["ANDA207763"],"brand_name":["Lamotrigine"],"generic_name":["LAMOTIRIGINE"],"is_original_packager":[true],"manufacturer_name":["Zydus Lifesciences Limited"],"nui":["N0000175753","N0000008486","N0000175751","N0000187061","N0000000191"],"package_ndc":["70771-1514-3","70771-1514-9","70771-1514-5","70771-1514-2","70771-1514-4","70771-1515-3","70771-1515-9","70771-1515-5","70771-1515-2","70771-1515-4","70771-1516-3","70771-1516-9","70771-1516-5","70771-1516-2","70771-1516-4","70771-1517-3","70771-1517-9","70771-1517-5","70771-1517-2","70771-1517-4","70771-1518-3","70771-1518-9","70771-1518-5","70771-1518-2","70771-1518-4","70771-1519-3","70771-1519-9","70771-1519-5","70771-1519-2","70771-1519-4"],"pharm_class_epc":["Anti-epileptic Agent [EPC]","Mood Stabilizer [EPC]"],"pharm_class_moa":["Organic Cation Transporter 2 Inhibitors [MoA]","Dihydrofolate Reductase Inhibitors [MoA]"],"pharm_class_pe":["Decreased Central Nervous System Disorganized Electrical Activity [PE]"],"product_ndc":["70771-1514","70771-1515","70771-1516","70771-1517","70771-1518","70771-1519"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"rxcui":["850087","850091","900156","900164","1098608","1146690"],"spl_id":["c2007dd5-98b7-47e2-8354-7ce432174a48"],"spl_set_id":["ecb7a528-699f-4e51-9887-dee60456da2f"],"substance_name":["LAMOTRIGINE"],"unii":["U3H27498KS"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1514-3 Lamotrigine extended-release tablets, 25 mg Rx only 30 tablets NDC 70771-1515-3 Lamotrigine extended-release tablets, 50 mg Rx only 30 tablets NDC 70771-1516-3 Lamotrigine extended-release tablets, 100 mg Rx only 30 tablets NDC 70771-1517-3 Lamotrigine extended-release tablets, 200 mg Rx only 30 tablets NDC 70771-1518-3 Lamotrigine extended-release tablets, 250 mg Rx only 30 tablets NDC 70771-1519-3 Lamotrigine extended-release tablets, 300 mg Rx only 30 tablets 25 mg label 50 mg label 100 mg label 200 mg label 250 mg label 300 mg label"],"set_id":"ecb7a528-699f-4e51-9887-dee60456da2f","spl_medguide":["SPL MEDGUIDE"],"spl_product_data_elements":["Lamotrigine Lamotirigine LAMOTRIGINE LAMOTRIGINE D&C YELLOW NO. 10 FERRIC OXIDE RED FERRIC OXIDE YELLOW GLYCERYL MONOSTEARATE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TRIETHYL CITRATE TITANIUM DIOXIDE WATER LIGHT YELLOW TO YELLOW ROUND 979 Lamotrigine Lamotirigine LAMOTRIGINE LAMOTRIGINE D&C YELLOW NO. 10 FD&C BLUE NO. 2 FERRIC OXIDE YELLOW GLYCERYL MONOSTEARATE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TRIETHYL CITRATE TITANIUM DIOXIDE WATER LIGHT GREEN TO GREEN ROUND 980 Lamotrigine Lamotirigine LAMOTRIGINE LAMOTRIGINE D&C YELLOW NO. 10 D&C RED NO. 27 FERRIC OXIDE YELLOW GLYCERYL MONOSTEARATE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TRIETHYL CITRATE TITANIUM DIOXIDE WATER LIGHT ORANGE TO ORANGE ROUND 981 Lamotrigine Lamotirigine LAMOTRIGINE LAMOTRIGINE FD&C BLUE NO. 2 FERROSOFERRIC OXIDE GLYCERYL MONOSTEARATE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TRIETHYL CITRATE TITANIUM DIOXIDE WATER LIGHT BLUE TO BLUE ROUND 982 Lamotrigine Lamotirigine LAMOTRIGINE LAMOTRIGINE FD&C BLUE NO. 2 FERROSOFERRIC OXIDE GLYCERYL MONOSTEARATE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TRIETHYL CITRATE TITANIUM DIOXIDE WATER CARMINIC ACID LIGHT PURPLE TO PURPLE OVAL 983 Lamotrigine Lamotirigine LAMOTRIGINE LAMOTRIGINE FD&C BLUE NO. 2 FERROSOFERRIC OXIDE GLYCERYL MONOSTEARATE HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 TRIETHYL CITRATE TITANIUM DIOXIDE WATER FERRIC OXIDE YELLOW LIGHT GRAY TO GRAY OVAL 984"],"spl_unclassified_section":[""],"version":"5"}