nityr

Generic: nitisinone

Labeler: cycle pharmaceuticals ltd.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name nityr
Generic Name nitisinone
Labeler cycle pharmaceuticals ltd.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

nitisinone 10 mg/1

Manufacturer
Cycle Pharmaceuticals Ltd.

Identifiers & Regulatory

Product NDC 70709-000
Product ID 70709-000_9e29c768-8b6d-40c0-a8ee-72dfcf4dbe92
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209449
Listing Expiration 2026-12-31
Marketing Start 2017-07-26

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 70709000
Hyphenated Format 70709-000

Supplemental Identifiers

RxCUI
1941464 1941470 1941471 1941473 1941474 1941476
UPC
0370709000602 0370709002606 0370709005607
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 nityr (source: ndc)
Generic Name nitisinone (source: ndc)
Application Number NDA209449 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (70709-000-60) / 60 TABLET in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

70709-000-60 1 BOTTLE, PLASTIC in 1 CARTON (70709-000-60) / 60 TABLET in 1 BOTTLE, PLASTIC

Ingredients (1)

nitisinone (10 mg/1)

Linked Drug Pages (1)

NITYR ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9e29c768-8b6d-40c0-a8ee-72dfcf4dbe92", "openfda": {"nui": ["N0000175809", "N0000175808", "N0000185504", "N0000193955", "N0000190110", "N0000190111"], "upc": ["0370709000602", "0370709002606", "0370709005607"], "unii": ["K5BN214699"], "rxcui": ["1941464", "1941470", "1941471", "1941473", "1941474", "1941476"], "spl_set_id": ["00fd1905-27e4-420e-8dc5-a69e4ddc1526"], "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": ["Cycle Pharmaceuticals Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (70709-000-60)  / 60 TABLET in 1 BOTTLE, PLASTIC", "package_ndc": "70709-000-60", "marketing_start_date": "20170726"}], "brand_name": "NITYR", "product_id": "70709-000_9e29c768-8b6d-40c0-a8ee-72dfcf4dbe92", "dosage_form": "TABLET", "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": "70709-000", "generic_name": "Nitisinone", "labeler_name": "Cycle Pharmaceuticals Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "NITYR", "active_ingredients": [{"name": "NITISINONE", "strength": "10 mg/1"}], "application_number": "NDA209449", "marketing_category": "NDA", "marketing_start_date": "20170726", "listing_expiration_date": "20261231"}