voydeya

Generic: danicopan

Labeler: alexion pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name voydeya
Generic Name danicopan
Labeler alexion pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

danicopan 100 mg/1

Manufacturer
Alexion Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 25682-043
Product ID 25682-043_8d2698b9-9dc6-48b2-b7a2-77aa8abab8cb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA218037
Listing Expiration 2026-12-31
Marketing Start 2024-03-29

Pharmacologic Class

Established (EPC)
complement factor d inhibitor [epc]
Mechanism of Action
complement factor d inhibitors [moa] p-glycoprotein inhibitors [moa] breast cancer resistance protein inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25682043
Hyphenated Format 25682-043

Supplemental Identifiers

RxCUI
2678957 2678963 2678965 2678967 2678968 2678969 2678970 2678971 2678972 2678973 2678974 2678975
UNII
JM8C1SFX0U
NUI
N0000194113 N0000194114 N0000185503 N0000190113

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 voydeya (source: ndc)
Generic Name danicopan (source: ndc)
Application Number NDA218037 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 4 BLISTER PACK in 1 CARTON (25682-043-04) / 42 TABLET, FILM COATED in 1 BLISTER PACK (25682-043-42)
  • 2 BOTTLE in 1 CARTON (25682-043-92) / 90 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (2)

25682-043-04 4 BLISTER PACK in 1 CARTON (25682-043-04) / 42 TABLET, FILM COATED in 1 BLISTER PACK (25682-043-42) 25682-043-92 2 BOTTLE in 1 CARTON (25682-043-92) / 90 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

danicopan (100 mg/1)

Linked Drug Pages (1)

Voydeya ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8d2698b9-9dc6-48b2-b7a2-77aa8abab8cb", "openfda": {"nui": ["N0000194113", "N0000194114", "N0000185503", "N0000190113"], "unii": ["JM8C1SFX0U"], "rxcui": ["2678957", "2678963", "2678965", "2678967", "2678968", "2678969", "2678970", "2678971", "2678972", "2678973", "2678974", "2678975"], "spl_set_id": ["ab8d1cbd-a28b-4d49-82ab-5c7460719ac7"], "pharm_class_epc": ["Complement Factor D Inhibitor [EPC]"], "pharm_class_moa": ["Complement Factor D Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Breast Cancer Resistance Protein Inhibitors [MoA]"], "manufacturer_name": ["Alexion Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 BLISTER PACK in 1 CARTON (25682-043-04)  / 42 TABLET, FILM COATED in 1 BLISTER PACK (25682-043-42)", "package_ndc": "25682-043-04", "marketing_start_date": "20240329"}, {"sample": false, "description": "2 BOTTLE in 1 CARTON (25682-043-92)  / 90 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "25682-043-92", "marketing_start_date": "20240329"}], "brand_name": "Voydeya", "product_id": "25682-043_8d2698b9-9dc6-48b2-b7a2-77aa8abab8cb", "dosage_form": "TABLET, FILM COATED", "product_ndc": "25682-043", "generic_name": "Danicopan", "labeler_name": "Alexion Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Voydeya", "active_ingredients": [{"name": "DANICOPAN", "strength": "100 mg/1"}], "application_number": "NDA218037", "marketing_category": "NDA", "marketing_start_date": "20240329", "listing_expiration_date": "20261231"}