turalio

Generic: pexidartinib hydrochloride

Labeler: daiichi sankyo inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name turalio
Generic Name pexidartinib hydrochloride
Labeler daiichi sankyo inc.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

pexidartinib hydrochloride 125 mg/1

Manufacturer
Daiichi Sankyo Inc.

Identifiers & Regulatory

Product NDC 65597-407
Product ID 65597-407_00774850-56e9-4fb9-85e8-586967a9a5f1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA211810
Listing Expiration 2026-12-31
Marketing Start 2023-02-01

Pharmacologic Class

Classes
colony stimulating factor receptor type 1 (csf-1r) inhibitors [moa] cytochrome p450 2b6 inhibitors [moa] cytochrome p450 3a inducers [moa] kinase inhibitor [epc] kinase inhibitors [moa] tyrosine kinase inhibitors [moa] ugt1a1 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65597407
Hyphenated Format 65597-407

Supplemental Identifiers

RxCUI
2626397 2626399
UNII
YS6WAI3XN7

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 turalio (source: ndc)
Generic Name pexidartinib hydrochloride (source: ndc)
Application Number NDA211810 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 125 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (65597-407-20) / 120 CAPSULE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (65597-407-28) / 28 CAPSULE in 1 BOTTLE
source: ndc

Packages (2)

65597-407-20 1 BOTTLE in 1 CARTON (65597-407-20) / 120 CAPSULE in 1 BOTTLE 65597-407-28 1 BOTTLE in 1 CARTON (65597-407-28) / 28 CAPSULE in 1 BOTTLE

Ingredients (1)

pexidartinib hydrochloride (125 mg/1)

Linked Drug Pages (1)

Turalio ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "00774850-56e9-4fb9-85e8-586967a9a5f1", "openfda": {"unii": ["YS6WAI3XN7"], "rxcui": ["2626397", "2626399"], "spl_set_id": ["7b0ec4bf-b2ac-49ee-96af-7740ad3f2e16"], "manufacturer_name": ["Daiichi Sankyo Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (65597-407-20)  / 120 CAPSULE in 1 BOTTLE", "package_ndc": "65597-407-20", "marketing_start_date": "20230201"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (65597-407-28)  / 28 CAPSULE in 1 BOTTLE", "package_ndc": "65597-407-28", "marketing_start_date": "20230201"}], "brand_name": "Turalio", "product_id": "65597-407_00774850-56e9-4fb9-85e8-586967a9a5f1", "dosage_form": "CAPSULE", "pharm_class": ["Colony Stimulating Factor Receptor Type 1 (CSF-1R) Inhibitors [MoA]", "Cytochrome P450 2B6 Inhibitors [MoA]", "Cytochrome P450 3A Inducers [MoA]", "Kinase Inhibitor [EPC]", "Kinase Inhibitors [MoA]", "Tyrosine Kinase Inhibitors [MoA]", "UGT1A1 Inhibitors [MoA]"], "product_ndc": "65597-407", "generic_name": "pexidartinib hydrochloride", "labeler_name": "Daiichi Sankyo Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Turalio", "active_ingredients": [{"name": "PEXIDARTINIB HYDROCHLORIDE", "strength": "125 mg/1"}], "application_number": "NDA211810", "marketing_category": "NDA", "marketing_start_date": "20230201", "listing_expiration_date": "20261231"}