Package 71904-100-01

Brand: galafold

Generic: migalastat hydrochloride
NDC Package

Package Facts

Identity

Package NDC 71904-100-01
Digits Only 7190410001
Product NDC 71904-100
Description

14 BLISTER PACK in 1 CARTON (71904-100-01) / 1 CAPSULE in 1 BLISTER PACK

Marketing

Marketing Status
Marketed Since 2018-08-10
Brand galafold
Generic migalastat hydrochloride
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "2da6bbb5-63ae-4405-a1ad-25429b9f7139", "openfda": {"upc": ["0371904100012"], "unii": ["CLY7M0XD20"], "rxcui": ["2054257", "2054263", "2054266", "2054275"], "spl_set_id": ["66dbd928-0f1c-48b1-a832-54e4abd9f1db"], "manufacturer_name": ["Amicus Therapeutics US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "14 BLISTER PACK in 1 CARTON (71904-100-01)  / 1 CAPSULE in 1 BLISTER PACK", "package_ndc": "71904-100-01", "marketing_start_date": "20180810"}], "brand_name": "Galafold", "product_id": "71904-100_2da6bbb5-63ae-4405-a1ad-25429b9f7139", "dosage_form": "CAPSULE", "product_ndc": "71904-100", "generic_name": "migalastat hydrochloride", "labeler_name": "Amicus Therapeutics US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Galafold", "active_ingredients": [{"name": "MIGALASTAT HYDROCHLORIDE", "strength": "123 mg/1"}], "application_number": "NDA208623", "marketing_category": "NDA", "marketing_start_date": "20180810", "listing_expiration_date": "20261231"}