Home NDC 25682-046 Voydeya
Product NDC 25682-046
11-digit product format 256820046
Labeler code 25682
Product ID 25682-046_cd0113b0-d5d6-4b03-9f6f-4d80bdcb71fe
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Danicopan
Dosage form KIT
Labeler Alexion Pharmaceuticals Inc.
Application NDA218037
Marketing category NDA
Marketing start 2024-03-29
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N218037-001 VOYDEYA DANICOPAN 50MG TABLET / ORAL RLD 2024-03-29 N218037-002 VOYDEYA DANICOPAN 100MG TABLET / ORAL RLD, RS 2024-03-29
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N218037-001 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 N218037-001 12076319 2038-08-02 U-3933 2024-09-24 N218037-002 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 N218037-002 12076319 2038-08-02 U-3933 2024-09-24
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N218037-001 VOYDEYA 50MG TABLET / ORAL RLD 2024-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218037-002 VOYDEYA 100MG TABLET / ORAL RLD, RS 2024-03-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218037-001 VOYDEYA 50MG TABLET / ORAL RLD 2024-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218037-002 VOYDEYA 100MG TABLET / ORAL RLD, RS 2024-03-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218037-001 VOYDEYA 50MG TABLET / ORAL RLD 2024-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218037-002 VOYDEYA 100MG TABLET / ORAL RLD, RS 2024-03-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218037-001 VOYDEYA 50MG TABLET / ORAL RLD 2024-03-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218037-002 VOYDEYA 100MG TABLET / ORAL RLD, RS 2024-03-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218037-001 VOYDEYA 50MG TABLET / ORAL RLD 2024-03-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218037-002 VOYDEYA 100MG TABLET / ORAL RLD, RS 2024-03-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218037-001 VOYDEYA 50MG TABLET / ORAL RLD 2024-03-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218037-002 VOYDEYA 100MG TABLET / ORAL RLD, RS 2024-03-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218037-001 VOYDEYA 50MG TABLET / ORAL RLD 2024-03-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218037-002 VOYDEYA 100MG TABLET / ORAL RLD, RS 2024-03-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218037-001 VOYDEYA 50MG TABLET / ORAL RLD 2024-03-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218037-002 VOYDEYA 100MG TABLET / ORAL RLD, RS 2024-03-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218037-001 VOYDEYA 50MG TABLET / ORAL RLD 2024-03-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218037-002 VOYDEYA 100MG TABLET / ORAL RLD, RS 2024-03-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N218037-001 VOYDEYA 50MG TABLET / ORAL RLD 2024-03-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N218037-002 VOYDEYA 100MG TABLET / ORAL RLD, RS 2024-03-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N218037-001 VOYDEYA 50MG TABLET / ORAL RLD 2024-03-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N218037-002 VOYDEYA 100MG TABLET / ORAL RLD, RS 2024-03-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N218037-001 VOYDEYA 50MG TABLET / ORAL RLD 2024-03-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N218037-002 VOYDEYA 100MG TABLET / ORAL RLD, RS 2024-03-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N218037-001 VOYDEYA 50MG TABLET / ORAL RLD 2024-03-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N218037-002 VOYDEYA 100MG TABLET / ORAL RLD, RS 2024-03-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N218037-001 VOYDEYA 50MG TABLET / ORAL RLD 2024-03-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N218037-002 VOYDEYA 100MG TABLET / ORAL RLD, RS 2024-03-29 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218037-001 VOYDEYA 50MG TABLET / ORAL RLD 2024-03-29 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218037-002 VOYDEYA 100MG TABLET / ORAL RLD, RS 2024-03-29 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 48 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N218037-001 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218037-001 12076319 2038-08-02 U-3933 2024-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218037-002 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N218037-002 12076319 2038-08-02 U-3933 2024-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218037-001 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218037-001 12076319 2038-08-02 U-3933 2024-09-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218037-002 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218037-002 12076319 2038-08-02 U-3933 2024-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218037-001 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218037-001 12076319 2038-08-02 U-3933 2024-09-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218037-002 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N218037-002 12076319 2038-08-02 U-3933 2024-09-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218037-001 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218037-001 12076319 2038-08-02 U-3933 2024-09-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218037-002 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218037-002 12076319 2038-08-02 U-3933 2024-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218037-001 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218037-001 12076319 2038-08-02 U-3933 2024-09-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218037-002 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218037-002 12076319 2038-08-02 U-3933 2024-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218037-001 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218037-001 12076319 2038-08-02 U-3933 2024-09-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218037-002 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218037-002 12076319 2038-08-02 U-3933 2024-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218037-001 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218037-001 12076319 2038-08-02 U-3933 2024-09-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218037-002 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218037-002 12076319 2038-08-02 U-3933 2024-09-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218037-001 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218037-002 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218037-001 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218037-001 12076319 2038-08-02 U-3933 2024-09-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218037-002 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218037-002 12076319 2038-08-02 U-3933 2024-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N218037-001 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N218037-001 12076319 2038-08-02 U-3933 2024-09-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N218037-002 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N218037-002 12076319 2038-08-02 U-3933 2024-09-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N218037-001 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N218037-002 9796741 2035-02-25 U-3933 Drug substance 2024-05-23 79d66fd596c7…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 60 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Voydeya
Listing expiration 2027-12-31 Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination JM8C1SFX0U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2678957 Internal RxNorm lookup 2678963 Internal RxNorm lookup 2678965 Internal RxNorm lookup 2678967 Internal RxNorm lookup 2678972 Internal RxNorm lookup 2678973 Internal RxNorm lookup 2678974 Internal RxNorm lookup 2678975 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 25682-040-90 Voydeya 90 in 1 BOTTLE TABLET, FILM COATED 90 50 mg 5 25682-043-90 Voydeya 90 in 1 BOTTLE TABLET, FILM COATED 90 100 mg 5 25682-046-92 Voydeya 1 in 1 CARTON KIT 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25682-046 VOYDEYA (DANICOPAN) TABLET, FILM COATED VOYDEYA (DANICOPAN) KIT [ALEXION PHARMACEUTICALS INC.] 3 Current NDC, 3 package rows 20241210_ab8d1cbd-a28b-4d49-82ab-5c7460719ac7.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Voydeya DANICOPAN Alexion Pharmaceuticals Inc. ab8d1cbd-a28b-4d49-82ab-5c7460719ac7 2026-05-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 218037 application number: NDA218037 ndc (product): 25682-046
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 25682-040-90 25682004090 90 in 1 BOTTLE Historical 25682-043-90 25682004390 90 in 1 BOTTLE Historical 25682-046-92 25682004692 1 KIT in 1 CARTON (25682-046-92) * 90 TABLET, FILM COATED in 1 BOTTLE (25682-040-90) * 90 TABLET, FILM COATED in 1 BOTTLE (25682-043-90) 1 kit 2024-03-29 No No Current