nitisinone

Generic: nitisinone

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitisinone
Generic Name nitisinone
Labeler bryant ranch prepack
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nitisinone 5 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-2235
Product ID 63629-2235_8daf42bc-595c-48fd-aa3b-cbabbadde0c8
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 636292235
Hyphenated Format 63629-2235

Supplemental Identifiers

RxCUI
351174
UNII
K5BN214699
NUI
N0000175809 N0000175808 N0000185504 N0000193955 N0000190110 N0000190111

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 (63629-2235-1) / 60 CAPSULE in 1 BOTTLE
source: ndc

Packages (1)

63629-2235-1 1 BOTTLE in 1 CARTON (63629-2235-1) / 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": "8daf42bc-595c-48fd-aa3b-cbabbadde0c8", "openfda": {"nui": ["N0000175809", "N0000175808", "N0000185504", "N0000193955", "N0000190110", "N0000190111"], "unii": ["K5BN214699"], "rxcui": ["351174"], "spl_set_id": ["8cec0318-9f55-4340-b14b-588635619251"], "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": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (63629-2235-1)  / 60 CAPSULE in 1 BOTTLE", "package_ndc": "63629-2235-1", "marketing_start_date": "20210322"}], "brand_name": "Nitisinone", "product_id": "63629-2235_8daf42bc-595c-48fd-aa3b-cbabbadde0c8", "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": "63629-2235", "generic_name": "Nitisinone", "labeler_name": "Bryant Ranch Prepack", "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"}