Home NDC 83860-025-01 VYKAT XR
Product NDC 83860-025
Requested package NDC 83860-025-01
11-digit product format 838600025
Labeler code 83860
Product ID 83860-025_b8413ebc-f835-4c45-9524-91bda45bd35f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name diazoxide choline
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Soleno Therapeutics, Inc.
Application NDA216665
Marketing category NDA
Marketing start 2025-03-26
Substance DIAZOXIDE CHOLINE
Active strength 25 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N216665-001 VYKAT XR DIAZOXIDE CHOLINE 25MG TABLET, EXTENDED RELEASE / ORAL RLD 2025-03-26 N216665-002 VYKAT XR DIAZOXIDE CHOLINE 75MG TABLET, EXTENDED RELEASE / ORAL RLD 2025-03-26 N216665-003 VYKAT XR DIAZOXIDE CHOLINE 150MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2025-03-26
Orange Book patents# Current patent rows page 1 of 1 · 18 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216665-001 7572789 2026-12-20 Drug substance, Drug product 2025-04-23 N216665-001 7799777 2029-03-05 Drug substance 2025-04-23 N216665-001 12178823 2035-11-12 U-4167 2025-04-23 N216665-001 12343348 2035-11-12 U-4211 2025-07-03 N216665-001 12419895 2035-11-12 U-4275 2025-10-06 N216665-001 9757384 2035-11-12 U-4167 2025-04-23 N216665-002 7572789 2026-12-20 Drug substance, Drug product 2025-04-23 N216665-002 7799777 2029-03-05 Drug substance 2025-04-23 N216665-002 12178823 2035-11-12 U-4167 2025-04-23 N216665-002 12343348 2035-11-12 U-4211 2025-07-03 N216665-002 12419895 2035-11-12 U-4275 2025-10-06 N216665-002 9757384 2035-11-12 U-4167 2025-04-23 N216665-003 7572789 2026-12-20 Drug substance, Drug product 2025-04-23 N216665-003 7799777 2029-03-05 Drug substance 2025-04-23 N216665-003 12178823 2035-11-12 U-4167 2025-04-23 N216665-003 12343348 2035-11-12 U-4211 2025-07-03 N216665-003 12419895 2035-11-12 U-4275 2025-10-06 N216665-003 9757384 2035-11-12 U-4167 2025-04-23
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 6 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 2026-09-14 22:38:34 2026-08 N216665-001 VYKAT XR 25MG TABLET, EXTENDED RELEASE / ORAL RLD 2025-03-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216665-002 VYKAT XR 75MG TABLET, EXTENDED RELEASE / ORAL RLD 2025-03-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216665-003 VYKAT XR 150MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2025-03-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216665-001 VYKAT XR 25MG TABLET, EXTENDED RELEASE / ORAL RLD 2025-03-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216665-002 VYKAT XR 75MG TABLET, EXTENDED RELEASE / ORAL RLD 2025-03-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216665-003 VYKAT XR 150MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2025-03-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216665-001 VYKAT XR 25MG TABLET, EXTENDED RELEASE / ORAL RLD 2025-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216665-002 VYKAT XR 75MG TABLET, EXTENDED RELEASE / ORAL RLD 2025-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216665-003 VYKAT XR 150MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2025-03-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216665-001 VYKAT XR 25MG TABLET, EXTENDED RELEASE / ORAL RLD 2025-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216665-002 VYKAT XR 75MG TABLET, EXTENDED RELEASE / ORAL RLD 2025-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216665-003 VYKAT XR 150MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2025-03-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216665-001 VYKAT XR 25MG TABLET, EXTENDED RELEASE / ORAL RLD 2025-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216665-002 VYKAT XR 75MG TABLET, EXTENDED RELEASE / ORAL RLD 2025-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N216665-003 VYKAT XR 150MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2025-03-26 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216665-001 VYKAT XR 25MG TABLET, EXTENDED RELEASE / ORAL RLD 2025-03-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216665-002 VYKAT XR 75MG TABLET, EXTENDED RELEASE / ORAL RLD 2025-03-26 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216665-003 VYKAT XR 150MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2025-03-26 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 105 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N216665-001 7572789 2026-12-20 Drug substance, Drug product 2025-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216665-001 7799777 2029-03-05 Drug substance 2025-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216665-001 12178823 2035-11-12 U-4167 2025-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216665-001 12343348 2035-11-12 U-4211 2025-07-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216665-001 12419895 2035-11-12 U-4275 2025-10-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216665-001 9757384 2035-11-12 U-4167 2025-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216665-002 7572789 2026-12-20 Drug substance, Drug product 2025-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216665-002 7799777 2029-03-05 Drug substance 2025-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216665-002 12178823 2035-11-12 U-4167 2025-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216665-002 12343348 2035-11-12 U-4211 2025-07-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216665-002 12419895 2035-11-12 U-4275 2025-10-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216665-002 9757384 2035-11-12 U-4167 2025-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216665-003 7572789 2026-12-20 Drug substance, Drug product 2025-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216665-003 7799777 2029-03-05 Drug substance 2025-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216665-003 12178823 2035-11-12 U-4167 2025-04-23 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216665-003 12343348 2035-11-12 U-4211 2025-07-03 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216665-003 12419895 2035-11-12 U-4275 2025-10-06 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216665-003 9757384 2035-11-12 U-4167 2025-04-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216665-001 7572789 2026-12-20 Drug substance, Drug product 2025-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216665-001 7799777 2029-03-05 Drug substance 2025-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216665-001 12178823 2035-11-12 U-4167 2025-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216665-001 12343348 2035-11-12 U-4211 2025-07-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216665-001 12419895 2035-11-12 U-4275 2025-10-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216665-001 9757384 2035-11-12 U-4167 2025-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216665-002 7572789 2026-12-20 Drug substance, Drug product 2025-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216665-002 7799777 2029-03-05 Drug substance 2025-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216665-002 12178823 2035-11-12 U-4167 2025-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216665-002 12343348 2035-11-12 U-4211 2025-07-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216665-002 12419895 2035-11-12 U-4275 2025-10-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216665-002 9757384 2035-11-12 U-4167 2025-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216665-003 7572789 2026-12-20 Drug substance, Drug product 2025-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216665-003 7799777 2029-03-05 Drug substance 2025-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216665-003 12178823 2035-11-12 U-4167 2025-04-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216665-003 12343348 2035-11-12 U-4211 2025-07-03 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216665-003 12419895 2035-11-12 U-4275 2025-10-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216665-003 9757384 2035-11-12 U-4167 2025-04-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216665-001 7572789 2026-12-20 Drug substance, Drug product 2025-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216665-001 7799777 2029-03-05 Drug substance 2025-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216665-001 12178823 2035-11-12 U-4167 2025-04-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216665-001 12343348 2035-11-12 U-4211 2025-07-03 011fe1cb6892…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base VYKAT XR
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIAZOXIDE CHOLINE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2U8NRZ7P8L Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 6 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2711548 Internal RxNorm lookup 2711556 Internal RxNorm lookup 2711559 Internal RxNorm lookup 2711562 Internal RxNorm lookup 2711565 Internal RxNorm lookup 2711568 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 83860-025-01 VYKAT XR 30 in 1 BOTTLE TABLET, FILM COATED 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83860-025 VYKAT XR (DIAZOXIDE CHOLINE) TABLET, FILM COATED [SOLENO THERAPEUTICS, INC.] 2 Current NDC, 1 package rows 20250410_0e745e85-9512-e360-e063-6394a90aebf1.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 Marketing start Sample Exclude flag Status 83860-025-01 83860002501 30 TABLET, FILM COATED in 1 BOTTLE (83860-025-01) 2025-03-26 No No Current