Package 0378-9045-05

Brand: cystagon

Generic: cysteamine bitartrate
NDC Package

Package Facts

Identity

Package NDC 0378-9045-05
Digits Only 0378904505
Product NDC 0378-9045
Description

500 CAPSULE in 1 BOTTLE, PLASTIC (0378-9045-05)

Marketing

Marketing Status
Marketed Since 2005-04-11
Brand cystagon
Generic cysteamine bitartrate
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "29dfd298-96ed-4a5f-a573-b24f5ffa618b", "openfda": {"upc": ["0303789045058", "0303789040053"], "unii": ["QO84GZ3TST"], "rxcui": ["209788", "209789", "309636", "309637"], "spl_set_id": ["f495b76d-96c6-48e5-8fa3-30a4336628eb"], "manufacturer_name": ["Mylan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 CAPSULE in 1 BOTTLE, PLASTIC (0378-9045-05)", "package_ndc": "0378-9045-05", "marketing_start_date": "20050411"}], "brand_name": "Cystagon", "product_id": "0378-9045_29dfd298-96ed-4a5f-a573-b24f5ffa618b", "dosage_form": "CAPSULE", "pharm_class": ["Cystine Depleting Agent [EPC]", "Cystine Disulfide Reduction [MoA]"], "product_ndc": "0378-9045", "generic_name": "cysteamine bitartrate", "labeler_name": "Mylan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cystagon", "active_ingredients": [{"name": "CYSTEAMINE BITARTRATE", "strength": "150 mg/1"}], "application_number": "NDA020392", "marketing_category": "NDA", "marketing_start_date": "20050411", "listing_expiration_date": "20261231"}