NDC 67544-656

Renagel

Renagel

Renagel is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Sevelamer Hydrochloride.

• Product ID: 67544-656_7bba784e-b2dd-4662-a66d-09246be23c7c
• NDC: 67544-656
• Product Type: Human Prescription Drug
• Proprietary Name: Renagel
• Generic Name: Renagel
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2008-06-06
• Marketing Category: NDA / NDA
• Application Number: NDA021179
• Labeler Name: Aphena Pharma Solutions - Tennessee, LLC
• Substance Name: SEVELAMER HYDROCHLORIDE
• Active Ingredient Strength: 800 mg/1
• Pharm Classes: Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 67544-656-79

2160 TABLET in 1 BOTTLE, PLASTIC (67544-656-79)

• Marketing Start Date: 2008-06-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67544-656-79 [67544065679]

Renagel TABLET

• Marketing Category: NDA
• Application Number: NDA021179
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2008-06-06
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
SEVELAMER HYDROCHLORIDE	800 mg/1

OpenFDA Data

• SPL SET ID: b27c1744-1d96-4f9f-b621-e24a795b7534
• Manufacturer:
  • Aphena Pharma Solutions - Tennessee, LLC
• UNII:
  • GLS2PGI8QG
• RxNorm Concept Unique ID - RxCUI:
  • 857224

Pharmacological Class

• Phosphate Binder [EPC]
• Phosphate Chelating Activity [MoA]

NDC Crossover Matching brand name "Renagel" or generic name "Renagel"

NDC	Brand Name	Generic Name
17856-0021	Renagel	Renagel
53808-0777	Renagel	Renagel
58468-0020	Renagel	Renagel
58468-0021	Renagel	sevelamer hydrochloride
67544-656	Renagel	Renagel
68151-4295	RENAGEL	Renagel