{"effective_time":"20210420","how_supplied":["HOW SUPPLIED 400mg (white to of white, round, biconvex, film coated tablets debossed with '121' on one side and plain on the other side) Bottles of 100 & 500","HOW SUPPLIED 600mg (white to off white, capsule shaped, biconvex, film coated tablets debossed with '122' on one side and plain on the other side) Bottles of 30, 50, 100 & 500","800 mg (white to off-white, capsule shaped, biconvex, film-coated​ tablets debossed with ‘123’ on one side and plain on other side)"],"id":"afa576a9-24b6-40ee-99f6-9126eb884bed","openfda":{"application_number":["ANDA090796"],"brand_name":["IBUPROFEN"],"generic_name":["IBUPROFEN"],"manufacturer_name":["Aphena Pharma Solutions - Tennessee, LLC"],"nui":["N0000000160","M0001335","N0000175722"],"original_packager_product_ndc":["49483-603"],"package_ndc":["71610-532-60","71610-532-80","71610-532-92"],"pharm_class_cs":["Anti-Inflammatory Agents, Non-Steroidal [CS]"],"pharm_class_epc":["Nonsteroidal Anti-inflammatory Drug [EPC]"],"pharm_class_moa":["Cyclooxygenase Inhibitors [MoA]"],"product_ndc":["71610-532"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"rxcui":["197806"],"spl_id":["afa576a9-24b6-40ee-99f6-9126eb884bed"],"spl_set_id":["77adb094-869c-44b4-8a4e-b739ac9cd701"],"substance_name":["IBUPROFEN"],"unii":["WK2XYI10QM"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 600 mg NDC 71610-532 - Ibuprofen, USP 600 mg Tablets - Rx Only Bottle Label 600 mg"],"set_id":"77adb094-869c-44b4-8a4e-b739ac9cd701","spl_medguide":["ibuprofen tablets 400 mg - 600 mg- 800 mg medguide MEDGUIDE IBUPROFEN TABLETS"],"spl_product_data_elements":["IBUPROFEN IBUPROFEN SILICON DIOXIDE CROSCARMELLOSE SODIUM MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL STARCH, PREGELATINIZED CORN TALC TITANIUM DIOXIDE IBUPROFEN IBUPROFEN 122"],"spl_unclassified_section":["Repackaging Information Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below: Count 600 mg 90 71610-532-60 180 71610-532-80 270 71610-532-92 Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children. Repackaged by: Cookeville, TN 38506 20210420JH Aphena Pharma Solutions - TN"],"spl_unclassified_section_table":["
Count600 mg
9071610-532-60
18071610-532-80
27071610-532-92
"],"version":"1"}