NDC codes

FDA NDC Directory
Product NDC (as listed)73154-050Labeler and product segments. Claims need a package NDC.
Product NDC at billing width73154-0050Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
73154-050-06731540050066 TABLET in 1 BOTTLE (73154-050-06)Marketed from Sep 12, 2019
73154-050-607315400506060 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

N473154005006 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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