{"effective_time":"20241130","id":"05217d4a-ad65-460c-b041-e17fda6eec59","openfda":{"application_number":["ANDA200816"],"brand_name":["LANSOPRAZOLE"],"generic_name":["LANSOPRAZOLE"],"is_original_packager":[true],"manufacturer_name":["Zydus Lifesciences Limited"],"nui":["N0000175525","N0000000147","N0000009724"],"package_ndc":["70771-1132-4","70771-1133-4"],"pharm_class_epc":["Proton Pump Inhibitor [EPC]"],"pharm_class_moa":["Proton Pump Inhibitors [MoA]"],"pharm_class_pe":["Inhibition Gastric Acid Secretion [PE]"],"product_ndc":["70771-1132","70771-1133"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"rxcui":["351260","351261"],"spl_id":["05217d4a-ad65-460c-b041-e17fda6eec59"],"spl_set_id":["76ffd38e-bea8-45a0-b6bd-82f0043ce64d"],"substance_name":["LANSOPRAZOLE"],"unii":["0K5C5T2QPG"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1132-4 Lansoprazole Delayed-release Orally Disintegrating Tablets, 15 mg R x only 100 Tablets (10 x 10 Unit Dose) NDC 70771-1133-4 Lansoprazole Delayed-release Orally Disintegrating Tablets, 30 mg R x only 100 Tablets (10 x 10 Unit Dose) Lansoprazole delayed-release orally disintegrating tablets, 15 mg Lansoprazole delayed-release orally disintegrating tablets, 30 mg"],"set_id":"76ffd38e-bea8-45a0-b6bd-82f0043ce64d","spl_medguide":["SPL MEDGUIDE"],"spl_product_data_elements":["LANSOPRAZOLE LANSOPRAZOLE LANSOPRAZOLE LANSOPRAZOLE ANHYDROUS CITRIC ACID ASPARTAME CELLULOSE, MICROCRYSTALLINE CROSPOVIDONE (15 MPA.S AT 5%) FERRIC OXIDE RED GLYCERYL MONOSTEARATE HYDROCHLORIC ACID HYPROMELLOSES MAGNESIUM CARBONATE MAGNESIUM STEARATE MANNITOL METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER POLYACRYLIC ACID (250000 MW) POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 SILICON DIOXIDE SODIUM HYDROXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN STRAWBERRY TALC TRIETHYL CITRATE XANTHAN GUM WHITE TO OFF-WHITE STRAWBERRY ROUND 771 LANSOPRAZOLE LANSOPRAZOLE LANSOPRAZOLE LANSOPRAZOLE ANHYDROUS CITRIC ACID ASPARTAME CELLULOSE, MICROCRYSTALLINE CROSPOVIDONE (15 MPA.S AT 5%) FERRIC OXIDE RED GLYCERYL MONOSTEARATE HYDROCHLORIC ACID HYPROMELLOSES MAGNESIUM CARBONATE MAGNESIUM STEARATE MANNITOL METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER POLYACRYLIC ACID (250000 MW) POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 SILICON DIOXIDE SODIUM HYDROXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO STARCH, CORN STRAWBERRY TALC TRIETHYL CITRATE XANTHAN GUM WHITE TO OFF-WHITE STRAWBERRY ROUND 772"],"spl_unclassified_section":[""],"version":"6"}