FDA.reportPublic FDA data

EXXUA

Product NDC
23594-153
11-digit product format
235940153
Labeler code
23594
Product ID
23594-153_414d62f1-85aa-cfa6-e063-6394a90a69fc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gepirone
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Aytu Therapeutics, LLC
Application
NDA021164
Marketing category
NDA
Marketing start
2025-10-01
Substance
GEPIRONE HYDROCHLORIDE
Active strength
72.6 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
EXXUA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GEPIRONE HYDROCHLORIDE72.6 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii80C9L8EP6V
Rxcui2672372, 2672379, 2672382, 2672385, 2672388, 2672391, 2672394, 2672397, 2732202, 2732203

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6f638e74-cd6e-451d-887a-7ed2461179ecProduct name120231013

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23594-153-30EXXUA30 in 1 BOTTLETABLET, EXTENDED RELEASE302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23594-153-30EA - Each23594-1532ce05da2-3076-4ffe-9de9-16b33623487112025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2732203{32 (24 HR gepirone 18.2 MG Extended Release Oral Tablet [Exxua]) } Pack [Exxua Titration Pack]BPCK0c78edd8-6acb-433c-9d34-2527da8d64e12
2732202{32 (24 HR gepirone 18.2 MG Extended Release Oral Tablet) } PackGPCK0c78edd8-6acb-433c-9d34-2527da8d64e12
2672379EXXUA 18.2 MG 24HR Extended Release Oral TabletPSN0c78edd8-6acb-433c-9d34-2527da8d64e12
2672385EXXUA 36.3 MG 24HR Extended Release Oral TabletPSN0c78edd8-6acb-433c-9d34-2527da8d64e12
2672391EXXUA 54.5 MG 24HR Extended Release Oral TabletPSN0c78edd8-6acb-433c-9d34-2527da8d64e12
2672397EXXUA 72.6 MG 24HR Extended Release Oral TabletPSN0c78edd8-6acb-433c-9d34-2527da8d64e12
2732203exxua Titration PackPSN0c78edd8-6acb-433c-9d34-2527da8d64e12
2672372gepirone 18.2 MG 24HR Extended Release Oral TabletPSN0c78edd8-6acb-433c-9d34-2527da8d64e12
2732202gepirone 18.2 MG 24HR Extended Release Oral Tablet (32) Titration PackPSN0c78edd8-6acb-433c-9d34-2527da8d64e12
2672382gepirone 36.3 MG 24HR Extended Release Oral TabletPSN0c78edd8-6acb-433c-9d34-2527da8d64e12
2672388gepirone 54.5 MG 24 HR Extended Release Oral TabletPSN0c78edd8-6acb-433c-9d34-2527da8d64e12
2672394gepirone 72.6 MG 24 HR Extended Release Oral TabletPSN0c78edd8-6acb-433c-9d34-2527da8d64e12
267237924 HR gepirone 18.2 MG Extended Release Oral Tablet [Exxua]SBD0c78edd8-6acb-433c-9d34-2527da8d64e12
267238524 HR gepirone 36.3 MG Extended Release Oral Tablet [Exxua]SBD0c78edd8-6acb-433c-9d34-2527da8d64e12
267239124 HR gepirone 54.5 MG Extended Release Oral Tablet [Exxua]SBD0c78edd8-6acb-433c-9d34-2527da8d64e12
267239724 HR gepirone 72.6 MG Extended Release Oral Tablet [Exxua]SBD0c78edd8-6acb-433c-9d34-2527da8d64e12
267237224 HR gepirone 18.2 MG Extended Release Oral TabletSCD0c78edd8-6acb-433c-9d34-2527da8d64e12
267238224 HR gepirone 36.3 MG Extended Release Oral TabletSCD0c78edd8-6acb-433c-9d34-2527da8d64e12
267238824 HR gepirone 54.5 MG Extended Release Oral TabletSCD0c78edd8-6acb-433c-9d34-2527da8d64e12
267239424 HR gepirone 72.6 MG Extended Release Oral TabletSCD0c78edd8-6acb-433c-9d34-2527da8d64e12
267237924 HR Exxua 18.2 MG Extended Release Oral TabletSY0c78edd8-6acb-433c-9d34-2527da8d64e12
267238524 HR Exxua 36.3 MG Extended Release Oral TabletSY0c78edd8-6acb-433c-9d34-2527da8d64e12
267239124 HR Exxua 54.5 MG Extended Release Oral TabletSY0c78edd8-6acb-433c-9d34-2527da8d64e12
267239724 HR Exxua 72.6 MG Extended Release Oral TabletSY0c78edd8-6acb-433c-9d34-2527da8d64e12
2672379Exxua 18.2 MG (equivalent to 20 MG gepirone hydrochloride) 24 HR Extended Release Oral TabletSY0c78edd8-6acb-433c-9d34-2527da8d64e12
2672385Exxua 36.3 MG (equivalent to 40 MG gepirone hydrochloride) 24 HR Extended Release Oral TabletSY0c78edd8-6acb-433c-9d34-2527da8d64e12
2672391Exxua 54.5 MG (equivalent to 60 MG gepirone hydrochloride) 24 HR Extended Release Oral TabletSY0c78edd8-6acb-433c-9d34-2527da8d64e12
2672397Exxua 72.6 MG (equivalent to 80 MG gepirone hydrochloride) 24 HR Extended Release Oral TabletSY0c78edd8-6acb-433c-9d34-2527da8d64e12
2732203Exxua Titration PackSY0c78edd8-6acb-433c-9d34-2527da8d64e12
2672372gepirone 18.2 MG (equivalent to 20 MG gepirone hydrochloride) 24 HR Extended Release Oral TabletSY0c78edd8-6acb-433c-9d34-2527da8d64e12
2732202gepirone 18.2 MG 24 HR Extended Release Oral Tablet Titration Pack, 32 TabletsSY0c78edd8-6acb-433c-9d34-2527da8d64e12
2672382gepirone 36.3 MG (equivalent to 40 MG gepirone hydrochloride) 24 HR Extended Release Oral TabletSY0c78edd8-6acb-433c-9d34-2527da8d64e12
2672388gepirone 54.5 MG (equivalent to 60 MG gepirone hydrochloride) 24 HR Extended Release Oral TabletSY0c78edd8-6acb-433c-9d34-2527da8d64e12
2672394gepirone 72.6 MG (equivalent to 80 MG gepirone hydrochloride) 24 HR Extended Release Oral TabletSY0c78edd8-6acb-433c-9d34-2527da8d64e12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
23594-153-302359401533030 TABLET, EXTENDED RELEASE in 1 BOTTLE (23594-153-30) 2025-10-01NoNoHistorical