FDA.reportPublic FDA data

VYKAT XR

Product NDC
83860-150
11-digit product format
838600150
Labeler code
83860
Product ID
83860-150_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
150 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VYKAT XR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIAZOXIDE CHOLINE150 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2U8NRZ7P8L
Rxcui2711548, 2711556, 2711559, 2711562, 2711565, 2711568

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
83860-150-01VYKAT XR30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83860-150-01EA - Each83860-15052d3af3c-c27e-4672-a3a8-99c2a279be1b12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83860-150VYKAT XR (DIAZOXIDE CHOLINE) TABLET, FILM COATED [SOLENO THERAPEUTICS, INC.]2Current NDC, 1 package rows20250410_0e745e85-9512-e360-e063-6394a90aebf1.zip

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
83860-150-018386001500130 TABLET, FILM COATED in 1 BOTTLE (83860-150-01) 2025-03-26NoNoCurrent