nitisinone

Generic: nitisinone

Labeler: analog pharma
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name nitisinone
Generic Name nitisinone
Labeler analog pharma
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

nitisinone 2 mg/1

Manufacturer
Analog Pharma

Identifiers & Regulatory

Product NDC 70505-202
Product ID 70505-202_f74e0d5c-aaae-4751-a24d-4d141dfcae61
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212390
Listing Expiration 2026-12-31
Marketing Start 2022-06-15

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 70505202
Hyphenated Format 70505-202

Supplemental Identifiers

RxCUI
351173 351174 351175 1798999
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 ANDA212390 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2 mg/1
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (70505-202-60) / 60 CAPSULE in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

70505-202-60 1 BOTTLE, PLASTIC in 1 CARTON (70505-202-60) / 60 CAPSULE in 1 BOTTLE, PLASTIC

Ingredients (1)

nitisinone (2 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": "f74e0d5c-aaae-4751-a24d-4d141dfcae61", "openfda": {"nui": ["N0000175809", "N0000175808", "N0000185504", "N0000193955", "N0000190110", "N0000190111"], "unii": ["K5BN214699"], "rxcui": ["351173", "351174", "351175", "1798999"], "spl_set_id": ["645c8387-30d5-4a86-a5d8-2f6b5df6d5f0"], "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": ["Analog Pharma"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (70505-202-60)  / 60 CAPSULE in 1 BOTTLE, PLASTIC", "package_ndc": "70505-202-60", "marketing_start_date": "20220615"}], "brand_name": "Nitisinone", "product_id": "70505-202_f74e0d5c-aaae-4751-a24d-4d141dfcae61", "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": "70505-202", "generic_name": "Nitisinone", "labeler_name": "Analog Pharma", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nitisinone", "active_ingredients": [{"name": "NITISINONE", "strength": "2 mg/1"}], "application_number": "ANDA212390", "marketing_category": "ANDA", "marketing_start_date": "20220615", "listing_expiration_date": "20261231"}