Prescription drug · NDA
XPHOZAH 10 mg (Tenapanor) NDC 73154-110
Tenapanor hydrochloride 10 mg/1 · Tablet, Film coated · Oral · Ardelyx, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73154-110-14 | 73154011014 | 14 TABLET, FILM COATED in 1 BOTTLE (73154-110-14)Marketed from Oct 17, 2023 | |
| 73154-110-60 | 73154011060 | 60 TABLET, FILM COATED in 1 BOTTLE (73154-110-60)Marketed from Oct 17, 2023 | |
| 73154-110-99 | 73154011099 | 14 TABLET, FILM COATED in 1 BOTTLE (73154-110-99)Marketed from Oct 17, 2023 · Sample package |
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)
- XPHOZAH 10 mg
- Generic name (nonproprietary)
- tenapanor
- Active ingredients
- Tenapanor hydrochloride — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Ardelyx, Inc.NDC labeler code 73154
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 213931
- Marketing start
- Listing expires
- Other FDA classes
- Organic Anion Transporting Polypeptide 2B1 Inhibitors (Mechanism)Sodium-Hydrogen Exchanger 3 Inhibitors (Mechanism)
- Identifiers
- Product ID 73154-110_4555be24-05c0-4145-80c4-2fbd64d08e52SPL ID 4555be24-05c0-4145-80c4-2fbd64d08e52SPL set ID c57e279c-0f1b-4238-81b7-4e0dc0cc60c5RxCUI 2669440, 2669446, 2669448, 2669450, 2669452, 2669454UNII 50605O2ZNS
- Pharmacologic class
- Sodium-Hydrogen Exchanger 3 Inhibitor
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
N473154011014followed by a unit qualifier and the quantityPackage 73154-0110-14. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
About NDC 73154-110
- What is NDC 73154-110?
- 73154-110 is the product NDC for XPHOZAH 10 mg (tenapanor), Tenapanor hydrochloride 10 mg/1 tablet, film coated, listed with the FDA by Ardelyx, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- XPHOZAH 10 mg (Tenapanor).
- What is the active ingredient?
- Tenapanor hydrochloride.
- Who is the labeler?
- Ardelyx, Inc., NDC labeler code 73154. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for XPHOZAH 10 mg?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under NDA 213931
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 |
|---|---|---|---|---|
| XPHOZAH 20 mgtenapanor | Tenapanor hydrochloride 20 mg/1 | Tablet, Film coatedOral | Ardelyx, Inc. | 73154-120 |
| XPHOZAH 30 mgtenapanor | Tenapanor hydrochloride 30 mg/1 | Tablet, Film coatedOral | Ardelyx, Inc. | 73154-130 |