Package 70518-4304-0
Brand: mirabegron
Generic: mirabegronPackage Facts
Identity
Package NDC
70518-4304-0
Digits Only
7051843040
Product NDC
70518-4304
Description
90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4304-0)
Marketing
Marketing Status
Brand
mirabegron
Generic
mirabegron
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "402d6915-bb65-7f50-e063-6394a90a2e46", "openfda": {"nui": ["N0000185008", "N0000185007", "N0000182137", "N0000190114", "N0000185503"], "unii": ["MVR3JL3B2V"], "rxcui": ["1300801"], "spl_set_id": ["5f7a1758-8691-4e53-96d6-a01626ee8140"], "pharm_class_epc": ["beta3-Adrenergic Agonist [EPC]"], "pharm_class_moa": ["Adrenergic beta3-Agonists [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-4304-0)", "package_ndc": "70518-4304-0", "marketing_start_date": "20250307"}], "brand_name": "Mirabegron", "product_id": "70518-4304_402d6915-bb65-7f50-e063-6394a90a2e46", "dosage_form": "TABLET, EXTENDED RELEASE", "pharm_class": ["Adrenergic beta3-Agonists [MoA]", "Cytochrome P450 2D6 Inhibitors [MoA]", "Cytochrome P450 3A Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "beta3-Adrenergic Agonist [EPC]"], "product_ndc": "70518-4304", "generic_name": "Mirabegron", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mirabegron", "active_ingredients": [{"name": "MIRABEGRON", "strength": "50 mg/1"}], "application_number": "ANDA209488", "marketing_category": "ANDA", "marketing_start_date": "20250307", "listing_expiration_date": "20261231"}