Prescription drug · NDA
Exxua (Gepirone) NDC 23594-153
Gepirone hydrochloride 72.6 mg/1 · Tablet, Extended release · Oral · Aytu Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 23594-153-30 | 23594015330 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (23594-153-30)Marketed from Oct 1, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Exxua
- Generic name (nonproprietary)
- gepirone
- Active ingredients
- Gepirone hydrochloride — 72.6 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Aytu Therapeutics, LLCNDC labeler code 23594
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021164
- Marketing start
- Listing expires
- Identifiers
- Product ID 23594-153_5694dd0b-7231-c5ba-e063-6394a90a9621SPL ID 5694dd0b-7231-c5ba-e063-6394a90a9621SPL set ID 0c78edd8-6acb-433c-9d34-2527da8d64e1RxCUI 2672372, 2672379, 2672382, 2672385, 2672388, 2672391, 2672394, 2672397, 2732202, 2732203UNII 80C9L8EP6VUPC 0323594150303, 0323594152307, 0323594150327, 0323594153304, 0323594151300
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N423594015330followed by a unit qualifier and the quantityPackage 23594-0153-30. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
EXXUA is indicated for the treatment of major depressive disorder (MDD) in adults. EXXUA is indicated for the treatment of major depressive disorder (MDD) in adults ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 23594-153
- What is NDC 23594-153?
- 23594-153 is the product NDC for Exxua (gepirone), Gepirone hydrochloride 72.6 mg/1 tablet, extended release, listed with the FDA by Aytu Therapeutics, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Exxua (Gepirone).
- What is the active ingredient?
- Gepirone hydrochloride.
- Who is the labeler?
- Aytu Therapeutics, LLC, NDC labeler code 23594. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Exxua?
- 3 other product NDCs are listed under this name. See all Exxua NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Exxua products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Exxuagepirone | Gepirone hydrochloride 18.2 mg/1 | Tablet, Extended releaseOral | Aytu Therapeutics, LLC | 23594-150 | 23594-0150-3023594-0150-32 |
| Exxuagepirone | Gepirone hydrochloride 36.3 mg/1 | Tablet, Extended releaseOral | Aytu Therapeutics, LLC | 23594-151 | 23594-0151-30 |
| Exxuagepirone | Gepirone hydrochloride 54.5 mg/1 | Tablet, Extended releaseOral | Aytu Therapeutics, LLC | 23594-152 | 23594-0152-30 |
Other NDCs under NDA 021164
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Exxuagepirone | Gepirone hydrochloride 54.5 mg/1 | Tablet, Extended releaseOral | Aytu Therapeutics, LLC | 23594-152 |
| Exxuagepirone | Gepirone hydrochloride 18.2 mg/1 | Tablet, Extended releaseOral | Aytu Therapeutics, LLC | 23594-150 |
| Exxuagepirone | Gepirone hydrochloride 36.3 mg/1 | Tablet, Extended releaseOral | Aytu Therapeutics, LLC | 23594-151 |