nitisinone

Generic: nitisinone

Labeler: endo usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitisinone
Generic Name nitisinone
Labeler endo usa, inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nitisinone 5 mg/1

Manufacturer
Endo USA, Inc.

Identifiers & Regulatory

Product NDC 0254-3021
Product ID 0254-3021_8d22274c-76b2-4da0-85e0-c0fc61c7db0e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211041
Listing Expiration 2026-12-31
Marketing Start 2019-10-04

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 02543021
Hyphenated Format 0254-3021

Supplemental Identifiers

RxCUI
351173 351174 351175
UPC
0302543022021 0302543020027 0302543021024
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 ANDA211041 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0254-3021-02) / 60 CAPSULE in 1 BOTTLE
source: ndc

Packages (1)

0254-3021-02 1 BOTTLE in 1 CARTON (0254-3021-02) / 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": "8d22274c-76b2-4da0-85e0-c0fc61c7db0e", "openfda": {"nui": ["N0000175809", "N0000175808", "N0000185504", "N0000193955", "N0000190110", "N0000190111"], "upc": ["0302543022021", "0302543020027", "0302543021024"], "unii": ["K5BN214699"], "rxcui": ["351173", "351174", "351175"], "spl_set_id": ["437868f5-1c9e-4b0f-8a03-77df8ac0900d"], "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": ["Endo USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0254-3021-02)  / 60 CAPSULE in 1 BOTTLE", "package_ndc": "0254-3021-02", "marketing_start_date": "20191004"}], "brand_name": "Nitisinone", "product_id": "0254-3021_8d22274c-76b2-4da0-85e0-c0fc61c7db0e", "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": "0254-3021", "generic_name": "Nitisinone", "labeler_name": "Endo USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitisinone", "active_ingredients": [{"name": "NITISINONE", "strength": "5 mg/1"}], "application_number": "ANDA211041", "marketing_category": "ANDA", "marketing_start_date": "20191004", "listing_expiration_date": "20261231"}