harliku

Generic: nitisinone

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

Drug Facts

Product Profile

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

nitisinone 2 mg/1

Manufacturer
Cycle Pharmaceuticals Ltd.

Identifiers & Regulatory

Product NDC 70709-112
Product ID 70709-112_2d883e57-720f-494e-be8f-db592ba0aa32
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA209449
Listing Expiration 2026-12-31
Marketing Start 2025-07-21

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 70709112
Hyphenated Format 70709-112

Supplemental Identifiers

RxCUI
1941474 2719722
UPC
0370709112602
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 harliku (source: ndc)
Generic Name nitisinone (source: ndc)
Application Number NDA209449 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (70709-112-60) / 60 TABLET in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

70709-112-60 1 BOTTLE, PLASTIC in 1 CARTON (70709-112-60) / 60 TABLET in 1 BOTTLE, PLASTIC

Ingredients (1)

nitisinone (2 mg/1)

Linked Drug Pages (1)

HARLIKU ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2d883e57-720f-494e-be8f-db592ba0aa32", "openfda": {"nui": ["N0000175809", "N0000175808", "N0000185504", "N0000193955", "N0000190110", "N0000190111"], "upc": ["0370709112602"], "unii": ["K5BN214699"], "rxcui": ["1941474", "2719722"], "spl_set_id": ["7cf67e24-d46b-4376-bbd0-0b973c406d0d"], "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 (70709-112-60)  / 60 TABLET in 1 BOTTLE, PLASTIC", "package_ndc": "70709-112-60", "marketing_start_date": "20250721"}], "brand_name": "HARLIKU", "product_id": "70709-112_2d883e57-720f-494e-be8f-db592ba0aa32", "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": "70709-112", "generic_name": "nitisinone", "labeler_name": "Cycle Pharmaceuticals Ltd.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HARLIKU", "active_ingredients": [{"name": "NITISINONE", "strength": "2 mg/1"}], "application_number": "NDA209449", "marketing_category": "NDA", "marketing_start_date": "20250721", "listing_expiration_date": "20261231"}