NDC 73154-050

IBSRELA

Tenapanor Hydrochloride

IBSRELA is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Ardelyx, Inc.. The primary component is Tenapanor Hydrochloride.

• Product ID: 73154-050_0b3e247c-3ec2-4b46-a2cf-b0a4b64bddb9
• NDC: 73154-050
• Product Type: Human Prescription Drug
• Proprietary Name: IBSRELA
• Generic Name: Tenapanor Hydrochloride
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2019-09-12
• Marketing Category: NDA / NDA
• Application Number: NDA211801
• Labeler Name: Ardelyx, Inc.
• Substance Name: TENAPANOR HYDROCHLORIDE
• Active Ingredient Strength: 53 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 73154-050-06

6 TABLET in 1 BOTTLE (73154-050-06)

• Marketing Start Date: 2019-09-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 73154-050-60 [73154005060]

IBSRELA TABLET

• Marketing Category: NDA
• Application Number: NDA211801
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-09-12

NDC 73154-050-06 [73154005006]

IBSRELA TABLET

• Marketing Category: NDA
• Application Number: NDA211801
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-09-12

Drug Details

Active Ingredients

Ingredient	Strength
TENAPANOR HYDROCHLORIDE	53.2 mg/1

OpenFDA Data

• SPL SET ID: 2102da5f-a1a0-4ac7-a1f6-38698cf7273a
• Manufacturer:
  • Ardelyx, Inc.
• UNII:
  • 50605O2ZNS
• RxNorm Concept Unique ID - RxCUI:
  • 2199679
  • 2199685