Package 75987-101-08

Brand: procysbi

Generic: cysteamine bitartrate
NDC Package

Package Facts

Identity

Package NDC 75987-101-08
Digits Only 7598710108
Product NDC 75987-101
Product ID 75987-101_374233b1-345c-4d9e-9bc0-e5aa2f9d8e1f
Description

250 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (75987-101-08)

Marketing

Marketing Status
Marketed Since 2013-04-30
Brand procysbi
Generic cysteamine bitartrate
Sample Package No

Linked Drug Pages (1)

PROCYSBI ndc-match (0.95)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "374233b1-345c-4d9e-9bc0-e5aa2f9d8e1f", "openfda": {"unii": ["QO84GZ3TST"], "rxcui": ["1421467", "1421473", "1421475", "1421477", "2284510", "2284514", "2284515", "2284516"], "spl_set_id": ["d3a3ec28-f746-463a-bb92-3bc8826db09e"], "manufacturer_name": ["Horizon Therapeutics USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "250 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (75987-101-08)", "package_ndc": "75987-101-08", "marketing_start_date": "20130430"}], "brand_name": "PROCYSBI", "product_id": "75987-101_374233b1-345c-4d9e-9bc0-e5aa2f9d8e1f", "dosage_form": "CAPSULE, DELAYED RELEASE PELLETS", "pharm_class": ["Cystine Depleting Agent [EPC]", "Cystine Disulfide Reduction [MoA]"], "product_ndc": "75987-101", "generic_name": "Cysteamine bitartrate", "labeler_name": "Horizon Therapeutics USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PROCYSBI", "active_ingredients": [{"name": "CYSTEAMINE BITARTRATE", "strength": "75 mg/1"}], "application_number": "NDA203389", "marketing_category": "NDA", "marketing_start_date": "20130430", "listing_expiration_date": "20261231"}