NDC 68151-4295

RENAGEL

Renagel

RENAGEL is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Carilion Materials Management. The primary component is Sevelamer Hydrochloride.

• Product ID: 68151-4295_659e4de8-1232-4c9e-ab20-7e0d3af01700
• NDC: 68151-4295
• 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: Carilion Materials Management
• Substance Name: SEVELAMER HYDROCHLORIDE
• Active Ingredient Strength: 400 mg/1
• Pharm Classes: Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 68151-4295-1

1 TABLET in 1 BLISTER PACK (68151-4295-1)

• Marketing Start Date: 2017-12-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68151-4295-1 [68151429501]

RENAGEL TABLET

• Marketing Category: NDA
• Application Number: NDA021179
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-12-28
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
SEVELAMER HYDROCHLORIDE	400 mg/1

OpenFDA Data

• SPL SET ID: 9281598e-60de-4f4f-8e01-0a7dfef92dd3
• Manufacturer:
  • Carilion Materials Management
• UNII:
  • GLS2PGI8QG
• RxNorm Concept Unique ID - RxCUI:
  • 857218
  • 857216

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