NDC 17856-0021

Renagel

Renagel

Renagel is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Atlantic Biologicals Corps. The primary component is Sevelamer Hydrochloride.

• Product ID: 17856-0021_42719fda-d898-4749-b561-f85a5e54cd06
• NDC: 17856-0021
• 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: Atlantic Biologicals Corps
• Substance Name: SEVELAMER HYDROCHLORIDE
• Active Ingredient Strength: 800 mg/1
• Pharm Classes: Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 17856-0021-2

1 TABLET in 1 POUCH (17856-0021-2)

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

NDC SPL Data Element Entries

NDC 17856-0021-2 [17856002102]

Renagel TABLET

• Marketing Category: NDA
• Application Number: NDA021179
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• 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: ee835dc1-36b7-4447-a5c6-5ed9e06a839d
• Manufacturer:
  • Atlantic Biologicals Corps
• 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