Package 66658-204-90

Brand: orfadin

Generic: nitisinone
NDC Package

Package Facts

Identity

Package NDC 66658-204-90
Digits Only 6665820490
Product NDC 66658-204
Description

1 BOTTLE, GLASS in 1 CARTON (66658-204-90) / 90 mL in 1 BOTTLE, GLASS

Marketing

Marketing Status
Marketed Since 2016-06-01
Brand orfadin
Generic nitisinone
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "463bdca4-b840-6f9f-e063-6294a90ab3b5", "openfda": {"nui": ["N0000175809", "N0000175808", "N0000185504", "N0000193955", "N0000190110", "N0000190111"], "unii": ["K5BN214699"], "rxcui": ["1790310", "1790317"], "spl_set_id": ["00307f42-748d-4227-8c6f-ed5f0a89ae0a"], "pharm_class_epc": ["4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 2E1 Inducers [MoA]", "Organic Anion Transporter 1 Inhibitors [MoA]", "Organic Anion Transporter 3 Inhibitors [MoA]"], "manufacturer_name": ["Swedish Orphan Biovitrum AB (publ)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (66658-204-90)  / 90 mL in 1 BOTTLE, GLASS", "package_ndc": "66658-204-90", "marketing_start_date": "20160601"}], "brand_name": "ORFADIN", "product_id": "66658-204_463bdca4-b840-6f9f-e063-6294a90ab3b5", "dosage_form": "SUSPENSION", "pharm_class": ["4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 2E1 Inducers [MoA]", "Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA]", "Organic Anion Transporter 1 Inhibitors [MoA]", "Organic Anion Transporter 3 Inhibitors [MoA]"], "product_ndc": "66658-204", "generic_name": "nitisinone", "labeler_name": "Swedish Orphan Biovitrum AB (publ)", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ORFADIN", "active_ingredients": [{"name": "NITISINONE", "strength": "4 mg/mL"}], "application_number": "NDA206356", "marketing_category": "NDA", "marketing_start_date": "20160601", "listing_expiration_date": "20261231"}