Package 68875-0101-2
Brand: gattex
Generic: teduglutidePackage Facts
Identity
Package NDC
68875-0101-2
Digits Only
6887501012
Product NDC
68875-0101
Description
30 VIAL in 1 CARTON (68875-0101-2) / .5 mL in 1 VIAL (68875-0101-1)
Marketing
Marketing Status
Brand
gattex
Generic
teduglutide
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["SUBCUTANEOUS"], "spl_id": "20ca0019-d3a4-4a8f-8dd4-67179d06e4dc", "openfda": {"nui": ["N0000190992", "N0000190990", "N0000175140", "N0000175452"], "unii": ["7M19191IKG"], "rxcui": ["1364472", "1364477", "1489307"], "spl_set_id": ["66b69c1e-b25c-44d3-b5ff-1c1de9a516fa"], "pharm_class_cs": ["Glucagon-Like Peptide 2 [Chemical/Ingredient]", "Analogs/Derivatives [Chemical/Ingredient]"], "pharm_class_epc": ["GLP-2 Analog [EPC]"], "pharm_class_moa": ["Glucagon-like Peptide-2 (GLP-2) Agonists [MoA]"], "manufacturer_name": ["Takeda Pharmaceuticals America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 VIAL in 1 CARTON (68875-0101-2) / .5 mL in 1 VIAL (68875-0101-1)", "package_ndc": "68875-0101-2", "marketing_start_date": "20121221"}], "brand_name": "Gattex", "product_id": "68875-0101_20ca0019-d3a4-4a8f-8dd4-67179d06e4dc", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Analogs/Derivatives [Chemical/Ingredient]", "GLP-2 Analog [EPC]", "Glucagon-Like Peptide 2 [Chemical/Ingredient]", "Glucagon-like Peptide-2 (GLP-2) Agonists [MoA]"], "product_ndc": "68875-0101", "generic_name": "teduglutide", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gattex", "active_ingredients": [{"name": "TEDUGLUTIDE", "strength": "5 mg/.5mL"}], "application_number": "NDA203441", "marketing_category": "NDA", "marketing_start_date": "20121221", "listing_expiration_date": "20261231"}