exxua

Generic: gepirone

Labeler: aytu therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name exxua
Generic Name gepirone
Labeler aytu therapeutics, llc
Dosage Form TABLET, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

gepirone hydrochloride 72.6 mg/1

Manufacturer
Aytu Therapeutics, LLC

Identifiers & Regulatory

Product NDC 23594-153
Product ID 23594-153_414d62f1-85aa-cfa6-e063-6394a90a69fc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021164
Listing Expiration 2026-12-31
Marketing Start 2025-10-01

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 23594153
Hyphenated Format 23594-153

Supplemental Identifiers

RxCUI
2672372 2672379 2672382 2672385 2672388 2672391 2672394 2672397 2732202 2732203
UPC
0323594150303 0323594152307 0323594153304 0323594151300
UNII
80C9L8EP6V

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name exxua (source: ndc)
Generic Name gepirone (source: ndc)
Application Number NDA021164 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 72.6 mg/1
source: ndc
Packaging
  • 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (23594-153-30)
source: ndc

Packages (1)

23594-153-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (23594-153-30)

Ingredients (1)

gepirone hydrochloride (72.6 mg/1)

Linked Drug Pages (1)

EXXUA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "414d62f1-85aa-cfa6-e063-6394a90a69fc", "openfda": {"upc": ["0323594150303", "0323594152307", "0323594153304", "0323594151300"], "unii": ["80C9L8EP6V"], "rxcui": ["2672372", "2672379", "2672382", "2672385", "2672388", "2672391", "2672394", "2672397", "2732202", "2732203"], "spl_set_id": ["0c78edd8-6acb-433c-9d34-2527da8d64e1"], "manufacturer_name": ["Aytu Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, EXTENDED RELEASE in 1 BOTTLE (23594-153-30)", "package_ndc": "23594-153-30", "marketing_start_date": "20251001"}], "brand_name": "EXXUA", "product_id": "23594-153_414d62f1-85aa-cfa6-e063-6394a90a69fc", "dosage_form": "TABLET, EXTENDED RELEASE", "product_ndc": "23594-153", "generic_name": "gepirone", "labeler_name": "Aytu Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "EXXUA", "active_ingredients": [{"name": "GEPIRONE HYDROCHLORIDE", "strength": "72.6 mg/1"}], "application_number": "NDA021164", "marketing_category": "NDA", "marketing_start_date": "20251001", "listing_expiration_date": "20261231"}