orfadin

Generic: nitisinone

Labeler: swedish orphan biovitrum ab (publ)
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name orfadin
Generic Name nitisinone
Labeler swedish orphan biovitrum ab (publ)
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

nitisinone 4 mg/mL

Manufacturer
Swedish Orphan Biovitrum AB (publ)

Identifiers & Regulatory

Product NDC 66658-204
Product ID 66658-204_463bdca4-b840-6f9f-e063-6294a90ab3b5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA206356
Listing Expiration 2026-12-31
Marketing Start 2016-06-01

Pharmacologic Class

Established (EPC)
4-hydroxyphenyl-pyruvate dioxygenase inhibitor [epc]
Mechanism of Action
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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66658204
Hyphenated Format 66658-204

Supplemental Identifiers

RxCUI
1790310 1790317
UNII
K5BN214699
NUI
N0000175809 N0000175808 N0000185504 N0000193955 N0000190110 N0000190111

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name orfadin (source: ndc)
Generic Name nitisinone (source: ndc)
Application Number NDA206356 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (66658-204-90) / 90 mL in 1 BOTTLE, GLASS
source: ndc

Packages (1)

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

Ingredients (1)

nitisinone (4 mg/mL)

Linked Drug Pages (1)

ORFADIN ndc-match (0.9)

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"}