{"effective_time":"20241205","id":"f845896f-d006-4f67-9de6-a734ca665025","openfda":{"application_number":["ANDA203686"],"brand_name":["METFORMIN HYDROCHLORIDE"],"generic_name":["METFORMIN HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Zydus Lifesciences Limited"],"package_ndc":["65841-809-16","65841-809-01","65841-809-05","65841-809-10","65841-809-30","65841-809-77","65841-810-16","65841-810-01","65841-810-05","65841-810-10","65841-810-30","65841-810-77","65841-811-16","65841-811-01","65841-811-05","65841-811-10","65841-811-30","65841-811-77"],"product_ndc":["65841-809","65841-810","65841-811"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"rxcui":["860975","861004","861010"],"spl_id":["f845896f-d006-4f67-9de6-a734ca665025"],"spl_set_id":["5043d03e-3c9d-4c96-b48d-187f02a1d27c"],"substance_name":["METFORMIN HYDROCHLORIDE"],"unii":["786Z46389E"],"upc":["0368382760012"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-809-01 in bottle of 100 tablets Metformin Hydrochloride Tablets USP, 500 mg Rx only 100 tablets NDC 65841-810-01 in bottle of 100 tablets Metformin Hydrochloride Tablets USP, 850 mg Rx only 100 tablets NDC 65841-811-01 in bottle of 100 tablets Metformin Hydrochloride Tablets USP, 1000 mg Rx only 100 tablets Image Image Image"],"set_id":"5043d03e-3c9d-4c96-b48d-187f02a1d27c","spl_product_data_elements":["METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE METFORMIN HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO WHITE TO OFF-WHITE ROUND 70;Z METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE METFORMIN HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO WHITE TO OFF-WHITE OVAL 69;Z METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE METFORMIN HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE CELLULOSE, MICROCRYSTALLINE SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO WHITE TO OFF-WHITE OVAL Z;71"],"spl_unclassified_section":[""],"version":"14"}