{"effective_time":"20251031","id":"1bf557de-bcff-476b-b7c3-c7f7b8ddbfb2","openfda":{"application_number":["ANDA208468"],"brand_name":["GLATIRAMER ACETATE"],"generic_name":["GLATIRAMER ACETATE"],"is_original_packager":[true],"manufacturer_name":["Italfarmaco SpA"],"package_ndc":["11797-764-03","11797-765-03"],"product_ndc":["11797-764","11797-765"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["SUBCUTANEOUS"],"rxcui":["1111641","1487361"],"spl_id":["1bf557de-bcff-476b-b7c3-c7f7b8ddbfb2"],"spl_set_id":["1b3a60de-2191-4b15-be69-01329da87711"],"substance_name":["GLATIRAMER ACETATE"],"unii":["5M691HL4BO"]},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 11797-764-03 ONCE DAILY Glatiramer Acetate Injection 20 mg/mL FOR SUBCUTANEOUS INJECTION ONLY 30 pre-filled syringe (3 carton box of 10 syringes) Each pre-filled syringe contains 1 mL Glatiramer Acetate Injection solution of: glatiramer acetate 20 mg, mannitol 40 mg (inactive ingredient). Dispense the enclosed Medication Guide to each patient zydus Pharmaceuticals USA Rx only NDC 11797-765-03 THREE TIMES A WEEK Glatiramer Acetate Injection 40 mg/mL FOR SUBCUTANEOUS INJECTION ONLY 12 Single Dose Pre-Filled Syringes Each pre-filled syringe contains 1 mL Glatiramer Acetate Injection solution of: glatiramer acetate 40 mg, mannitol 40 mg (inactive ingredient). Dispense the enclosed Medication Guide to each patient zydus Pharmaceuticals USA Rx only 20 mg container label 20 mg container label"],"set_id":"1b3a60de-2191-4b15-be69-01329da87711","spl_product_data_elements":["GLATIRAMER ACETATE glatiramer acetate GLATIRAMER ACETATE GLATIRAMER MANNITOL WATER GLATIRAMER ACETATE glatiramer acetate GLATIRAMER ACETATE GLATIRAMER MANNITOL WATER"],"spl_unclassified_section":[""],"version":"1"}