{"effective_time":"20260406","id":"4ed45b55-9dca-64fa-e063-6394a90ab09a","openfda":{},"package_label_principal_display_panel":["100 mg Tablet Bottle Label NDC: 87500-100-11 100 mg Tablet Bottle Label SCEDAMIN TM (Hydroxyurea) 100 mg per Tablet For Oral Administration RX Only 60 Tablets Store at 20-25 o C (68-77 o F); excursions permitted between 15 o C and 30 o C (59 o F and 86 o F) Protect from moisture. Manufactured in the United States for Export Only Distributed by Yunigen Kenya Limited (See image name: 100mg_bottle) 100 mg Bottle","100 mg Tablet Carton Label (1 Bottle) NDC: 87500-100-30 SCEDAMINTM (Hydroxyurea) 100 mg per Tablet For Oral Administration RX Only 60 Tablets Store at 20-25oC (68-77oF); excursions permitted between 15oC and 30oC (59oF and 86oF) Protect from moisture. Manufactured in the United States for Export Only Distributed by Yunigen Kenya Limited Yunigen, Inc. (See image name: 100mg_carton_1bottle) 100 mg Carton 1 Bottle","100 mg Tablet Blister Label (Back) NDC: 87500-100-21 SCEDAMINTM (Hydroxyurea) 100 mg per Tablet For Oral Administration RX Only For Export Only Manufactured iby Yunigen, Inc. Distributed by Yunigen Kenya Limited B/N: EXP: (See image name: 100mg_blister_back) 100 mg Blister Back","100 mg Tablet Carton Label (4 Blisters) NDC:87500-100-40 SCEDAMIN TM (Hydroxyurea) 100 mg per Tablet For Oral Administration RX Only 60 Tablets Store at 20-25 o C (68-77 o F); excursions permitted between 15 o C and 30 o C (59 o F and 86 o F) Protect from moisture. Export Only Yunigen, Inc. LOT: EXP: (See image name: 100mg_carton_4blisters) 100 mg Carton 4 Blisters","500 mg Tablet Bottle Label NDC: 87500-101-11 SCEDAMIN TM (Hydroxyurea) 500 mg per Tablet For Oral Administration RX Only 60 Tablets Store at 20-25 o C (68-77 o F); excursions permitted between 15 o C and 30 o C (59 o F and 86 o F) Protect from moisture. Manufactured in the United States for Export Only Distributed by Yunigen Kenya Limited LOT: EXP: (See image name: 500mg_bottle attched) 500 mg Bottle","500 mg Tablet Carton Label (1 Bottle) NDC: 87500-101-30 SCEDAMIN TM (Hydroxyurea) 500 mg per Tablet For Oral Administration RX Only 60 Tablets Store at 20-25 o C (68-77 o F); excursions permitted between 15 o C and 30 o C (59 o F and 86 o F) Protect from moisture. Lot: EXP: Manufactured in the United States for Export Only Distributed by Yunigen Kenya Limited (See image name: 500mg_carton_1bottle) 500 mg Carton 1 Bottle","500 mg Tablet Blister Label (Back) NDC: 87500-101-20 SCEDAMIN TM (Hydroxyurea) 500 mg per Tablet For Oral Administration RX Only For Export Only Manufactured by Yunigen, Inc. Distributed by Yunigen Kenya Limited B/N: EXP: (See image name: 500mg_blister_back) 500 mg Blister Back","500 mg Tablet Carton Label (6 Blisters) NDC: 87500-101-41 SCEDAMIN TM (Hydroxyurea) 500 mg per Tablet For Oral Administration RX Only 60 Tablets Store at 20-25 o C (68-77 o F); excursions permitted between 15 o C and 30 o C (59 o F and 86 o F) Protect from moisture. Manufactured in the United States for Export Only Distributed by Yunigen Kenya Limited LOT: EXP: (See image name: 500mg_carton_6blisters) 500 mg Carton 6 Blisters"],"set_id":"4dc74ada-f633-3f1a-e063-6394a90a191e","spl_product_data_elements":["SCEDAMIN Hydroxyurea MICROCRYSTALLINE CELLULOSE HYDROXYUREA HYDROXYUREA SILICON DIOXIDE SODIUM STEARYL FUMARATE ISOPROPYL ALCOHOL DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER SCM White to Off-white SCEDAMIN Hydroxyurea DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER ISOPROPYL ALCOHOL SILICON DIOXIDE SODIUM STEARYL FUMARATE HYDROXYUREA HYDROXYUREA MICROCRYSTALLINE CELLULOSE White to off-white oval shaped tablet with half-scoring on both sides White to off-white SC;SC"],"version":"2"}