VYKAT XR

Product NDC
83860-025
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N216665-001VYKAT XRDIAZOXIDE CHOLINE25MGTABLET, EXTENDED RELEASE / ORALRLD2025-03-26
N216665-002VYKAT XRDIAZOXIDE CHOLINE75MGTABLET, EXTENDED RELEASE / ORALRLD2025-03-26
N216665-003VYKAT XRDIAZOXIDE CHOLINE150MGTABLET, EXTENDED RELEASE / ORALRLD, RS2025-03-26

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N216665-00175727892026-12-20Drug substance, Drug product2025-04-23
N216665-00177997772029-03-05Drug substance2025-04-23
N216665-001121788232035-11-12U-41672025-04-23
N216665-001123433482035-11-12U-42112025-07-03
N216665-001124198952035-11-12U-42752025-10-06
N216665-00197573842035-11-12U-41672025-04-23
N216665-00275727892026-12-20Drug substance, Drug product2025-04-23
N216665-00277997772029-03-05Drug substance2025-04-23
N216665-002121788232035-11-12U-41672025-04-23
N216665-002123433482035-11-12U-42112025-07-03
N216665-002124198952035-11-12U-42752025-10-06
N216665-00297573842035-11-12U-41672025-04-23
N216665-00375727892026-12-20Drug substance, Drug product2025-04-23
N216665-00377997772029-03-05Drug substance2025-04-23
N216665-003121788232035-11-12U-41672025-04-23
N216665-003123433482035-11-12U-42112025-07-03
N216665-003124198952035-11-12U-42752025-10-06
N216665-00397573842035-11-12U-41672025-04-23

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N216665-001NP2028-03-26
N216665-001ODE-5322032-03-26
N216665-002NP2028-03-26
N216665-002ODE-5322032-03-26
N216665-003NP2028-03-26
N216665-003ODE-5322032-03-26

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N216665-001VYKAT XR25MGTABLET, EXTENDED RELEASE / ORALRLD2025-03-2684e616aacf4f…
2026-09-14 22:38:342026-08N216665-002VYKAT XR75MGTABLET, EXTENDED RELEASE / ORALRLD2025-03-2684e616aacf4f…
2026-09-14 22:38:342026-08N216665-003VYKAT XR150MGTABLET, EXTENDED RELEASE / ORALRLD, RS2025-03-2684e616aacf4f…
2026-08-18 06:07:402026-07N216665-001VYKAT XR25MGTABLET, EXTENDED RELEASE / ORALRLD2025-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07N216665-002VYKAT XR75MGTABLET, EXTENDED RELEASE / ORALRLD2025-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07N216665-003VYKAT XR150MGTABLET, EXTENDED RELEASE / ORALRLD, RS2025-03-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N216665-001VYKAT XR25MGTABLET, EXTENDED RELEASE / ORALRLD2025-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216665-002VYKAT XR75MGTABLET, EXTENDED RELEASE / ORALRLD2025-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216665-003VYKAT XR150MGTABLET, EXTENDED RELEASE / ORALRLD, RS2025-03-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216665-001VYKAT XR25MGTABLET, EXTENDED RELEASE / ORALRLD2025-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216665-002VYKAT XR75MGTABLET, EXTENDED RELEASE / ORALRLD2025-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216665-003VYKAT XR150MGTABLET, EXTENDED RELEASE / ORALRLD, RS2025-03-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N216665-001VYKAT XR25MGTABLET, EXTENDED RELEASE / ORALRLD2025-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N216665-002VYKAT XR75MGTABLET, EXTENDED RELEASE / ORALRLD2025-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N216665-003VYKAT XR150MGTABLET, EXTENDED RELEASE / ORALRLD, RS2025-03-266a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N216665-001VYKAT XR25MGTABLET, EXTENDED RELEASE / ORALRLD2025-03-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N216665-002VYKAT XR75MGTABLET, EXTENDED RELEASE / ORALRLD2025-03-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N216665-003VYKAT XR150MGTABLET, EXTENDED RELEASE / ORALRLD, RS2025-03-26a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 3 · 105 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N216665-00175727892026-12-20Drug substance, Drug product2025-04-2384e616aacf4f…
2026-09-14 22:38:342026-08N216665-00177997772029-03-05Drug substance2025-04-2384e616aacf4f…
2026-09-14 22:38:342026-08N216665-001121788232035-11-12U-41672025-04-2384e616aacf4f…
2026-09-14 22:38:342026-08N216665-001123433482035-11-12U-42112025-07-0384e616aacf4f…
2026-09-14 22:38:342026-08N216665-001124198952035-11-12U-42752025-10-0684e616aacf4f…
2026-09-14 22:38:342026-08N216665-00197573842035-11-12U-41672025-04-2384e616aacf4f…
2026-09-14 22:38:342026-08N216665-00275727892026-12-20Drug substance, Drug product2025-04-2384e616aacf4f…
2026-09-14 22:38:342026-08N216665-00277997772029-03-05Drug substance2025-04-2384e616aacf4f…
2026-09-14 22:38:342026-08N216665-002121788232035-11-12U-41672025-04-2384e616aacf4f…
2026-09-14 22:38:342026-08N216665-002123433482035-11-12U-42112025-07-0384e616aacf4f…
2026-09-14 22:38:342026-08N216665-002124198952035-11-12U-42752025-10-0684e616aacf4f…
2026-09-14 22:38:342026-08N216665-00297573842035-11-12U-41672025-04-2384e616aacf4f…
2026-09-14 22:38:342026-08N216665-00375727892026-12-20Drug substance, Drug product2025-04-2384e616aacf4f…
2026-09-14 22:38:342026-08N216665-00377997772029-03-05Drug substance2025-04-2384e616aacf4f…
2026-09-14 22:38:342026-08N216665-003121788232035-11-12U-41672025-04-2384e616aacf4f…
2026-09-14 22:38:342026-08N216665-003123433482035-11-12U-42112025-07-0384e616aacf4f…
2026-09-14 22:38:342026-08N216665-003124198952035-11-12U-42752025-10-0684e616aacf4f…
2026-09-14 22:38:342026-08N216665-00397573842035-11-12U-41672025-04-2384e616aacf4f…
2026-08-18 06:07:402026-07N216665-00175727892026-12-20Drug substance, Drug product2025-04-23caaa826d4ba7…
2026-08-18 06:07:402026-07N216665-00177997772029-03-05Drug substance2025-04-23caaa826d4ba7…
2026-08-18 06:07:402026-07N216665-001121788232035-11-12U-41672025-04-23caaa826d4ba7…
2026-08-18 06:07:402026-07N216665-001123433482035-11-12U-42112025-07-03caaa826d4ba7…
2026-08-18 06:07:402026-07N216665-001124198952035-11-12U-42752025-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07N216665-00197573842035-11-12U-41672025-04-23caaa826d4ba7…
2026-08-18 06:07:402026-07N216665-00275727892026-12-20Drug substance, Drug product2025-04-23caaa826d4ba7…
2026-08-18 06:07:402026-07N216665-00277997772029-03-05Drug substance2025-04-23caaa826d4ba7…
2026-08-18 06:07:402026-07N216665-002121788232035-11-12U-41672025-04-23caaa826d4ba7…
2026-08-18 06:07:402026-07N216665-002123433482035-11-12U-42112025-07-03caaa826d4ba7…
2026-08-18 06:07:402026-07N216665-002124198952035-11-12U-42752025-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07N216665-00297573842035-11-12U-41672025-04-23caaa826d4ba7…
2026-08-18 06:07:402026-07N216665-00375727892026-12-20Drug substance, Drug product2025-04-23caaa826d4ba7…
2026-08-18 06:07:402026-07N216665-00377997772029-03-05Drug substance2025-04-23caaa826d4ba7…
2026-08-18 06:07:402026-07N216665-003121788232035-11-12U-41672025-04-23caaa826d4ba7…
2026-08-18 06:07:402026-07N216665-003123433482035-11-12U-42112025-07-03caaa826d4ba7…
2026-08-18 06:07:402026-07N216665-003124198952035-11-12U-42752025-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07N216665-00397573842035-11-12U-41672025-04-23caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N216665-00175727892026-12-20Drug substance, Drug product2025-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216665-00177997772029-03-05Drug substance2025-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216665-001121788232035-11-12U-41672025-04-23011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216665-001123433482035-11-12U-42112025-07-03011fe1cb6892…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N216665-001NP2028-03-2684e616aacf4f…
2026-09-14 22:38:342026-08N216665-001ODE-5322032-03-2684e616aacf4f…
2026-09-14 22:38:342026-08N216665-002NP2028-03-2684e616aacf4f…
2026-09-14 22:38:342026-08N216665-002ODE-5322032-03-2684e616aacf4f…
2026-09-14 22:38:342026-08N216665-003NP2028-03-2684e616aacf4f…
2026-09-14 22:38:342026-08N216665-003ODE-5322032-03-2684e616aacf4f…
2026-08-18 06:07:402026-07N216665-001NP2028-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07N216665-001ODE-5322032-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07N216665-002NP2028-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07N216665-002ODE-5322032-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07N216665-003NP2028-03-26caaa826d4ba7…
2026-08-18 06:07:402026-07N216665-003ODE-5322032-03-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N216665-001NP2028-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216665-002NP2028-03-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216665-003NP2028-03-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216665-001NP2028-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216665-002NP2028-03-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216665-003NP2028-03-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N216665-001NP2028-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N216665-002NP2028-03-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N216665-003NP2028-03-266a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N216665-001NP2028-03-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N216665-001ODE-5322032-03-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N216665-002NP2028-03-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N216665-002ODE-5322032-03-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N216665-003NP2028-03-26a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N216665-003ODE-5322032-03-26a50c72e98297…

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
IngredientStrength
DIAZOXIDE CHOLINE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2U8NRZ7P8LInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2711548Internal RxNorm lookup
2711556Internal RxNorm lookup
2711559Internal RxNorm lookup
2711562Internal RxNorm lookup
2711565Internal RxNorm lookup
2711568Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0e745e85-9512-e360-e063-6394a90aebf1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9a8e650a-7aae-491c-b4cb-53c9bf46f42dProduct name120260112
dca952e2-dead-7d30-59c8-ab2d6e0c38a2Product name320210127

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83860-025-01VYKAT XR30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83860-025-01EA - Each83860-02547f4ccd2-e821-4224-98d0-b5810b672e5512025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83860-025VYKAT XR (DIAZOXIDE CHOLINE) TABLET, FILM COATED [SOLENO THERAPEUTICS, INC.]2Current NDC, 1 package rows20250410_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VYKAT XRDIAZOXIDE CHOLINESoleno Therapeutics, Inc.0e745e85-9512-e360-e063-6394a90aebf12025-03-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 216665
application number: NDA216665
ndc (product): 83860-025

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2711548diazoxide choline 150 MG 24HR Extended Release Oral TabletPSN0e745e85-9512-e360-e063-6394a90aebf12
2711559diazoxide choline 25 MG 24HR Extended Release Oral TabletPSN0e745e85-9512-e360-e063-6394a90aebf12
2711565diazoxide choline 75 MG 24HR Extended Release Oral TabletPSN0e745e85-9512-e360-e063-6394a90aebf12
2711556vykat XR 150 MG 24HR Extended Release Oral TabletPSN0e745e85-9512-e360-e063-6394a90aebf12
2711562vykat XR 25 MG 24HR Extended Release Oral TabletPSN0e745e85-9512-e360-e063-6394a90aebf12
2711568vykat XR 75 MG 24HR Extended Release Oral TabletPSN0e745e85-9512-e360-e063-6394a90aebf12
271155624 HR diazoxide choline 150 MG Extended Release Oral Tablet [Vykat]SBD0e745e85-9512-e360-e063-6394a90aebf12
271156224 HR diazoxide choline 25 MG Extended Release Oral Tablet [Vykat]SBD0e745e85-9512-e360-e063-6394a90aebf12
271156824 HR diazoxide choline 75 MG Extended Release Oral Tablet [Vykat]SBD0e745e85-9512-e360-e063-6394a90aebf12
271154824 HR diazoxide choline 150 MG Extended Release Oral TabletSCD0e745e85-9512-e360-e063-6394a90aebf12
271155924 HR diazoxide choline 25 MG Extended Release Oral TabletSCD0e745e85-9512-e360-e063-6394a90aebf12
271156524 HR diazoxide choline 75 MG Extended Release Oral TabletSCD0e745e85-9512-e360-e063-6394a90aebf12
2711548diazoxide choline 150 MG 24 HR Extended Release Oral TabletSY0e745e85-9512-e360-e063-6394a90aebf12
2711559diazoxide choline 25 MG 24 HR Extended Release Oral TabletSY0e745e85-9512-e360-e063-6394a90aebf12
2711565diazoxide choline 75 MG 24 HR Extended Release Oral TabletSY0e745e85-9512-e360-e063-6394a90aebf12
2711556Vykat XR 150 MG 24 HR Extended Release Oral TabletSY0e745e85-9512-e360-e063-6394a90aebf12
2711562Vykat XR 25 MG 24 HR Extended Release Oral TabletSY0e745e85-9512-e360-e063-6394a90aebf12
2711568Vykat XR 75 MG 24 HR Extended Release Oral TabletSY0e745e85-9512-e360-e063-6394a90aebf12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
83860-025-018386000250130 TABLET, FILM COATED in 1 BOTTLE (83860-025-01) 2025-03-26NoNoCurrent