Home NDC 64406-250 SKYCLARYS
Product NDC 64406-250
11-digit product format 644060250
Labeler code 64406
Product ID 64406-250_4fa5df55-d5bf-44d1-856e-937b48e69bb0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name omaveloxolone
Dosage form CAPSULE
Route ORAL
Labeler Biogen
Application NDA216718
Marketing category NDA
Marketing start 2023-02-28
Substance OMAVELOXOLONE
Active strength 50 mg/1
Pharmacologic classes Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA]
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N216718-001 SKYCLARYS OMAVELOXOLONE 50MG CAPSULE / ORAL RLD, RS 2023-02-28
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216718-001 11091430 2029-04-20 U-3552 2023-03-29 N216718-001 11919838 2029-04-20 U-3862 2024-04-03 N216718-001 11919838 2029-04-20 U-3863 2024-04-03 N216718-001 8440854 2029-04-20 Drug product 2023-03-29 N216718-001 9670147 2029-04-20 Drug substance 2023-03-29 N216718-001 8124799 2029-12-03 Drug substance 2023-03-29 N216718-001 8993640 2033-04-24 Drug substance, Drug product 2023-03-29 N216718-001 9701709 2033-04-24 Drug substance, Drug product 2023-03-29
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N216718-001 M-270 2027-12-20 N216718-001 NCE 2028-02-28 N216718-001 ODE-427 2030-02-28
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 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216718-001 SKYCLARYS 50MG CAPSULE / ORAL RLD, RS 2023-02-28 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 5 · 168 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 N216718-001 11091430 2029-04-20 U-3552 2023-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216718-001 11919838 2029-04-20 U-3862 2024-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216718-001 11919838 2029-04-20 U-3863 2024-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216718-001 8440854 2029-04-20 Drug product 2023-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216718-001 9670147 2029-04-20 Drug substance 2023-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216718-001 8124799 2029-12-03 Drug substance 2023-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216718-001 8993640 2033-04-24 Drug substance, Drug product 2023-03-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216718-001 9701709 2033-04-24 Drug substance, Drug product 2023-03-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216718-001 11091430 2029-04-20 U-3552 2023-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216718-001 11919838 2029-04-20 U-3862 2024-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216718-001 11919838 2029-04-20 U-3863 2024-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216718-001 8440854 2029-04-20 Drug product 2023-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216718-001 9670147 2029-04-20 Drug substance 2023-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216718-001 8124799 2029-12-03 Drug substance 2023-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216718-001 8993640 2033-04-24 Drug substance, Drug product 2023-03-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216718-001 9701709 2033-04-24 Drug substance, Drug product 2023-03-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216718-001 11091430 2029-04-20 U-3552 2023-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216718-001 11919838 2029-04-20 U-3862 2024-04-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216718-001 11919838 2029-04-20 U-3863 2024-04-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216718-001 8440854 2029-04-20 Drug product 2023-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216718-001 9670147 2029-04-20 Drug substance 2023-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216718-001 8124799 2029-12-03 Drug substance 2023-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216718-001 8993640 2033-04-24 Drug substance, Drug product 2023-03-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216718-001 9701709 2033-04-24 Drug substance, Drug product 2023-03-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216718-001 11091430 2029-04-20 U-3552 2023-03-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216718-001 11919838 2029-04-20 U-3862 2024-04-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216718-001 11919838 2029-04-20 U-3863 2024-04-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216718-001 8440854 2029-04-20 Drug product 2023-03-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216718-001 9670147 2029-04-20 Drug substance 2023-03-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216718-001 8124799 2029-12-03 Drug substance 2023-03-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216718-001 8993640 2033-04-24 Drug substance, Drug product 2023-03-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216718-001 9701709 2033-04-24 Drug substance, Drug product 2023-03-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216718-001 11091430 2029-04-20 U-3552 2023-03-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216718-001 11919838 2029-04-20 U-3862 2024-04-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216718-001 11919838 2029-04-20 U-3863 2024-04-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216718-001 8440854 2029-04-20 Drug product 2023-03-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216718-001 9670147 2029-04-20 Drug substance 2023-03-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216718-001 8124799 2029-12-03 Drug substance 2023-03-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216718-001 8993640 2033-04-24 Drug substance, Drug product 2023-03-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216718-001 9701709 2033-04-24 Drug substance, Drug product 2023-03-29 b8a1b40f171c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 50 observed states.
Additional Listing Data#
Finished product Yes
Brand name base SKYCLARYS
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OMAVELOXOLONE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination G69Z98951Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2631936 Internal RxNorm lookup 2631942 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 64406-250-90 SKYCLARYS 90 in 1 BOTTLE CAPSULE 90 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64406-250 SKYCLARYS (OMAVELOXOLONE) CAPSULE [BIOGEN] 7 Current NDC, 1 package rows 20250109_2709e870-df3d-f30f-e063-6394a90aeda1.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 64406-250-90 64406025090 90 CAPSULE in 1 BOTTLE (64406-250-90) 90 capsule 2024-11-15 No No Current