{"effective_time":"20241125","id":"aabb5533-5d41-49a3-b8b6-14627af57311","openfda":{"application_number":["ANDA079029"],"brand_name":["Amiodarone hydrochloride"],"generic_name":["AMIODARONE HYDROCHLORIDE"],"is_original_packager":[true],"manufacturer_name":["Zydus Lifesciences Limited"],"package_ndc":["65841-840-06","65841-631-06","65841-631-14","65841-631-05","65841-631-10","65841-631-77","65841-841-06"],"product_ndc":["65841-631","65841-840","65841-841"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"rxcui":["833528","834348","835956"],"spl_id":["aabb5533-5d41-49a3-b8b6-14627af57311"],"spl_set_id":["3e8db251-e3c5-4fba-be9a-6044a92f0beb"],"substance_name":["AMIODARONE HYDROCHLORIDE"],"unii":["976728SY6Z"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-840-06 Amiodarone Hydrochloride Tablets USP, 100 mg 30 Tablets Rx only NDC 65841-631-14 in bottle of 60 tablets Amiodarone Hydrochloride Tablets, 200 mg Rx only NDC 65841-841-06 Amiodarone Hydrochloride Tablets USP, 400 mg 30 Tablets Rx only 100 mg label Amiodarone Hydrochloride Tablets, 200 mg 400 mg label"],"set_id":"3e8db251-e3c5-4fba-be9a-6044a92f0beb","spl_medguide":[""],"spl_product_data_elements":["Amiodarone hydrochloride Amiodarone hydrochloride AMIODARONE HYDROCHLORIDE AMIODARONE LACTOSE MONOHYDRATE MAGNESIUM STEARATE SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE STARCH, CORN OFF-WHITE ROUND 297 Amiodarone hydrochloride Amiodarone hydrochloride AMIODARONE HYDROCHLORIDE AMIODARONE LACTOSE MONOHYDRATE MAGNESIUM STEARATE SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO POVIDONE STARCH, CORN WHITE TO OFF-WHITE ROUND ZE;65 Amiodarone hydrochloride Amiodarone hydrochloride AMIODARONE HYDROCHLORIDE AMIODARONE LACTOSE MONOHYDRATE MAGNESIUM STEARATE SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO ALUMINUM OXIDE STARCH, CORN POVIDONE D&C YELLOW NO. 10 FERRIC OXIDE RED FERRIC OXIDE YELLOW PALE YELLOW TO YELLOW ROUND 2;98"],"version":"10"}