nitisinone

Generic: nitisinone

Labeler: eton pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitisinone
Generic Name nitisinone
Labeler eton pharmaceuticals, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nitisinone 5 mg/1

Manufacturer
Eton Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 71863-120
Product ID 71863-120_42c7c79b-1aa1-12bc-e063-6394a90a5ff8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216201
Listing Expiration 2026-12-31
Marketing Start 2024-01-15

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 71863120
Hyphenated Format 71863-120

Supplemental Identifiers

RxCUI
351173 351174 351175 1798999
UPC
0371863119605 0371863120601 0371863122605
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 nitisinone (source: ndc)
Generic Name nitisinone (source: ndc)
Application Number ANDA216201 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (71863-120-60) / 60 CAPSULE in 1 BOTTLE
source: ndc

Packages (1)

71863-120-60 1 BOTTLE in 1 CARTON (71863-120-60) / 60 CAPSULE in 1 BOTTLE

Ingredients (1)

nitisinone (5 mg/1)

Linked Drug Pages (1)

Nitisinone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "42c7c79b-1aa1-12bc-e063-6394a90a5ff8", "openfda": {"nui": ["N0000175809", "N0000175808", "N0000185504", "N0000193955", "N0000190110", "N0000190111"], "upc": ["0371863119605", "0371863120601", "0371863122605"], "unii": ["K5BN214699"], "rxcui": ["351173", "351174", "351175", "1798999"], "spl_set_id": ["dc5e4875-fcd7-408c-88c9-4a715f4384b6"], "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": ["Eton Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (71863-120-60)  / 60 CAPSULE in 1 BOTTLE", "package_ndc": "71863-120-60", "marketing_start_date": "20240115"}], "brand_name": "Nitisinone", "product_id": "71863-120_42c7c79b-1aa1-12bc-e063-6394a90a5ff8", "dosage_form": "CAPSULE", "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": "71863-120", "generic_name": "Nitisinone", "labeler_name": "Eton Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitisinone", "active_ingredients": [{"name": "NITISINONE", "strength": "5 mg/1"}], "application_number": "ANDA216201", "marketing_category": "ANDA", "marketing_start_date": "20240115", "listing_expiration_date": "20261231"}