Prescription drug · NDA
Ibsrela (Tenapanor hydrochloride) NDC 73154-050
Tenapanor hydrochloride 53.2 mg/1 · Tablet · Oral · Ardelyx, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73154-050-06 | 73154005006 | 6 TABLET in 1 BOTTLE (73154-050-06)Marketed from Sep 12, 2019 | |
| 73154-050-60 | 73154005060 | 60 TABLET in 1 BOTTLE (73154-050-60)Marketed from Sep 12, 2019 |
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)
- Ibsrela
- Generic name (nonproprietary)
- tenapanor hydrochloride
- Active ingredients
- Tenapanor hydrochloride — 53.2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Ardelyx, Inc.NDC labeler code 73154
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 211801
- Marketing start
- Listing expires
- Other FDA classes
- Organic Anion Transporting Polypeptide 2B1 Inhibitors (Mechanism)Sodium-Hydrogen Exchanger 3 Inhibitors (Mechanism)
- Identifiers
- Product ID 73154-050_f077d878-d495-417c-b464-3e7c0c831be7SPL ID f077d878-d495-417c-b464-3e7c0c831be7SPL set ID 2102da5f-a1a0-4ac7-a1f6-38698cf7273aRxCUI 2199679, 2199685UNII 50605O2ZNSUPC 0373154050604, 0373154050062
- 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
N473154005006followed by a unit qualifier and the quantityPackage 73154-0050-06. 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)
IBSRELA is indicated for treatment of irritable bowel syndrome with constipation (IBS-C) in adults. IBSRELA is a sodium/hydrogen exchanger 3 (NHE3) inhibitor indicated for treatment of irritable bowel syndrome with constipation (IBS-C) in adults. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 73154-050
- What is NDC 73154-050?
- 73154-050 is the product NDC for Ibsrela (tenapanor hydrochloride), Tenapanor hydrochloride 53.2 mg/1 tablet, listed with the FDA by Ardelyx, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ibsrela (Tenapanor hydrochloride).
- 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 Ibsrela?
- 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.