Package 71904-300-02
Brand: opfolda
Generic: miglustatPackage Facts
Identity
Package NDC
71904-300-02
Digits Only
7190430002
Product NDC
71904-300
Description
24 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-02) / 1 CAPSULE in 1 BOTTLE, PLASTIC
Marketing
Marketing Status
Brand
opfolda
Generic
miglustat
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "82a91fa0-6c38-452c-a5d0-2c2f7355f540", "openfda": {"nui": ["N0000175783", "N0000020019", "N0000194077", "N0000194078"], "upc": ["0371904300016", "0371904300023", "0371904300030"], "unii": ["ADN3S497AZ"], "rxcui": ["2667426", "2667432"], "spl_set_id": ["d7c38298-37db-5a80-e053-2995a90aee40"], "pharm_class_epc": ["Glucosylceramide Synthase Inhibitor [EPC]", "Enzyme Stabilizer [EPC]"], "pharm_class_moa": ["Glucosylceramide Synthase Inhibitors [MoA]", "Enzyme Stabilizers [MoA]"], "manufacturer_name": ["AMICUS THERAPEUTICS US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-01) / 1 CAPSULE in 1 BOTTLE, PLASTIC", "package_ndc": "71904-300-01", "marketing_start_date": "20231011"}, {"sample": false, "description": "24 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-02) / 1 CAPSULE in 1 BOTTLE, PLASTIC", "package_ndc": "71904-300-02", "marketing_start_date": "20231011"}, {"sample": false, "description": "100 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (71904-300-03) / 1 CAPSULE in 1 BOTTLE, PLASTIC", "package_ndc": "71904-300-03", "marketing_start_date": "20231011"}], "brand_name": "OPFOLDA", "product_id": "71904-300_82a91fa0-6c38-452c-a5d0-2c2f7355f540", "dosage_form": "CAPSULE", "pharm_class": ["Enzyme Stabilizer [EPC]", "Enzyme Stabilizers [MoA]", "Glucosylceramide Synthase Inhibitor [EPC]", "Glucosylceramide Synthase Inhibitors [MoA]"], "product_ndc": "71904-300", "generic_name": "miglustat", "labeler_name": "AMICUS THERAPEUTICS US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "OPFOLDA", "active_ingredients": [{"name": "MIGLUSTAT", "strength": "65 mg/1"}], "application_number": "NDA215211", "marketing_category": "NDA", "marketing_start_date": "20231011", "listing_expiration_date": "20261231"}