{"effective_time":"20241130","id":"900483ef-de89-464c-a324-8bfaa8f137a6","openfda":{"application_number":["ANDA203293"],"brand_name":["Memantine hydrochloride"],"generic_name":["MEMANTINE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Zydus Lifesciences Limited"],"package_ndc":["70771-1321-3","70771-1321-9","70771-1321-2","70771-1321-4","70771-1322-3","70771-1322-9","70771-1322-2","70771-1322-4","70771-1323-3","70771-1323-9","70771-1323-2","70771-1323-4","70771-1324-3","70771-1324-9","70771-1324-2","70771-1324-4"],"product_ndc":["70771-1321","70771-1322","70771-1323","70771-1324"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"rxcui":["996594","996603","996609","996615"],"spl_id":["900483ef-de89-464c-a324-8bfaa8f137a6"],"spl_set_id":["ec825bef-2313-45c2-8858-b43197680155"],"substance_name":["MEMANTINE HYDROCHLORIDE"],"unii":["JY0WD0UA60"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Memantine Hydrochloride Extended-release Capsules, 7 mg NDC 70771-1321-3 30 Counts Memantine Hydrochloride Extended-release Capsules, 14 mg 70771-1322-3 30 Counts Memantine Hydrochloride Extended-release Capsules, 21 mg NDC 70771-1323-3 30 Counts Memantine Hydrochloride Extended-release Capsules, 28 mg NDC 70771-1324-3 30 Counts Memantine Hydrochloride Extended-Release Capsules, 7 mg Memantine Hydrochloride Extended-Release Capsules, 14 mg Memantine Hydrochloride Extended-release Capsules, 21 mg Memantine Hydrochloride Extended-release Capsules, 28 mg"],"set_id":"ec825bef-2313-45c2-8858-b43197680155","spl_product_data_elements":["Memantine hydrochloride Memantine hydrochloride MEMANTINE HYDROCHLORIDE MEMANTINE AMMONIA ALCOHOL BUTYL ALCOHOL ETHYLCELLULOSE (7 MPA.S) GELATIN HYPROMELLOSES FERROSOFERRIC OXIDE ISOPROPYL ALCOHOL POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE SUCROSE TALC TRIETHYL CITRATE TITANIUM DIOXIDE WATER WHITE WHITE CAPSULE 546 Memantine hydrochloride Memantine hydrochloride MEMANTINE HYDROCHLORIDE MEMANTINE AMMONIA ALCOHOL BUTYL ALCOHOL ETHYLCELLULOSE (7 MPA.S) FERROSOFERRIC OXIDE FD&C BLUE NO. 1 FD&C RED NO. 3 FD&C YELLOW NO. 6 FERRIC OXIDE YELLOW GELATIN HYPROMELLOSES ISOPROPYL ALCOHOL POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE SUCROSE TALC TRIETHYL CITRATE TITANIUM DIOXIDE WATER LIGHT-BLUE GREEN CAPSULE 547 Memantine hydrochloride Memantine hydrochloride MEMANTINE HYDROCHLORIDE MEMANTINE AMMONIA ALCOHOL BUTYL ALCOHOL ETHYLCELLULOSE (7 MPA.S) FERROSOFERRIC OXIDE FD&C BLUE NO. 2 FERRIC OXIDE YELLOW GELATIN HYPROMELLOSES ISOPROPYL ALCOHOL POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE SUCROSE TALC TRIETHYL CITRATE TITANIUM DIOXIDE WATER WHITE GREEN CAPSULE 548 Memantine hydrochloride Memantine hydrochloride MEMANTINE HYDROCHLORIDE MEMANTINE AMMONIA ALCOHOL BUTYL ALCOHOL ETHYLCELLULOSE (7 MPA.S) FERROSOFERRIC OXIDE FD&C BLUE NO. 2 FERRIC OXIDE YELLOW GELATIN HYPROMELLOSES ISOPROPYL ALCOHOL POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE SUCROSE TALC TRIETHYL CITRATE TITANIUM DIOXIDE WATER LIGHT-GREEN LIGHT-GREEN CAPSULE 549"],"spl_unclassified_section":[""],"version":"5"}