Home NDC 25682-043 Voydeya
Product NDC 25682-043
11-digit product format 256820043
Labeler code 25682
Product ID 25682-043_cd0113b0-d5d6-4b03-9f6f-4d80bdcb71fe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Danicopan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Alexion Pharmaceuticals Inc.
Application NDA218037
Marketing category NDA
Marketing start 2024-03-29
Substance DANICOPAN
Active strength 100 mg/1
Pharmacologic classes Breast Cancer Resistance Protein Inhibitors [MoA], Complement Factor D Inhibitor [EPC], Complement Factor D Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Voydeya
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DANICOPAN 100 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii JM8C1SFX0U Rxcui 2678957, 2678963, 2678965, 2678967, 2678972, 2678973, 2678974, 2678975
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 25682-043-90 Voydeya 90 in 1 BOTTLE TABLET, FILM COATED 90 100 mg 5 25682-043-92 Voydeya 90 in 1 BOTTLE TABLET, FILM COATED 90 5 25682-043-92 Voydeya 2 in 1 CARTON TABLET, FILM COATED 2 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25682-043 VOYDEYA (DANICOPAN) TABLET, FILM COATED VOYDEYA (DANICOPAN) KIT [ALEXION PHARMACEUTICALS INC.] 3 Current NDC, 2 package rows 20241210_ab8d1cbd-a28b-4d49-82ab-5c7460719ac7.zip
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2678973 {180 (danicopan 100 MG Oral Tablet [Voydeya]) } Pack [Voydeya 200 MG Dose Bottle] BPCK ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 5 2678975 {90 (danicopan 100 MG Oral Tablet [Voydeya]) / 90 (danicopan 50 MG Oral Tablet [Voydeya]) } Pack [Voydeya 150 MG Dose Bottle] BPCK ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 5 2678972 {180 (danicopan 100 MG Oral Tablet) } Pack GPCK ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 5 2678974 {90 (danicopan 100 MG Oral Tablet) / 90 (danicopan 50 MG Oral Tablet) } Pack GPCK ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 5 2678965 danicopan 100 MG Oral Tablet PSN ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 5 2678974 danicopan 150 MG Dose, 2 Bottle Kit PSN ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 5 2678972 danicopan 200 MG Dose, 2 Bottle Kit PSN ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 5 2678957 danicopan 50 MG Oral Tablet PSN ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 5 2678967 Voydeya 100 MG Oral Tablet PSN ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 5 2678975 Voydeya 150 MG Dose, 2 Bottle Kit PSN ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 5 2678973 Voydeya 200 MG Dose, 2 Bottle Kit PSN ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 5 2678963 Voydeya 50 MG Oral Tablet PSN ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 5 2678967 danicopan 100 MG Oral Tablet [Voydeya] SBD ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 5 2678963 danicopan 50 MG Oral Tablet [Voydeya] SBD ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 5 2678965 danicopan 100 MG Oral Tablet SCD ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 5 2678957 danicopan 50 MG Oral Tablet SCD ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 5 2678974 danicopan 150 MG Dose, 2 Bottle Kit SY ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 5 2678972 danicopan 200 MG Dose, 2 Bottle Kit SY ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 5 2678967 Voydeya 100 MG Oral Tablet SY ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 5 2678975 Voydeya 150 MG Dose, 2 Bottle Kit SY ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 5 2678973 Voydeya 200 MG Dose, 2 Bottle Kit SY ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 5 2678963 Voydeya 50 MG Oral Tablet SY ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 5
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 25682-043-90 25682004390 90 in 1 BOTTLE Historical 25682-043-92 25682004392 2 BOTTLE in 1 CARTON (25682-043-92) / 90 TABLET, FILM COATED in 1 BOTTLE 2 bottle 2024-03-29 No No Current