NDC 58468-0021

Renagel

Sevelamer Hydrochloride

Renagel is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Genzyme Corporation. The primary component is Sevelamer Hydrochloride.

• Product ID: 58468-0021_500d269a-adb9-499c-ad8b-d9aaa43e1ba9
• NDC: 58468-0021
• Product Type: Human Prescription Drug
• Proprietary Name: Renagel
• Generic Name: Sevelamer Hydrochloride
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2008-06-06
• Marketing Category: NDA / NDA
• Application Number: NDA021179
• Labeler Name: Genzyme Corporation
• 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: 2023-12-31

Packaging

NDC 58468-0021-1

180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58468-0021-1)

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

NDC SPL Data Element Entries

NDC 58468-0021-3 [58468002103]

Renagel TABLET

• Marketing Category: NDA
• Application Number: NDA021179
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2008-06-06
• Marketing End Date: 2017-12-13

NDC 58468-0021-1 [58468002101]

Renagel TABLET

• Marketing Category: NDA
• Application Number: NDA021179
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2008-06-06

Drug Details

Active Ingredients

Ingredient	Strength
SEVELAMER HYDROCHLORIDE	800 mg/1

OpenFDA Data

• SPL SET ID: 5e30120b-f2bf-43a0-86b2-44ae996dc681
• Manufacturer:
  • Genzyme Corporation
• UNII:
  • GLS2PGI8QG
• RxNorm Concept Unique ID - RxCUI:
  • 857216
  • 857224

Pharmacological Class

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

Medicade Reported Pricing

58468002101 RENAGEL 800 MG TABLET

Pricing Unit: EA | Drug Type:

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

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
0955-1048	Sevelamer Hydrochloride	Sevelamer Hydrochloride
60687-449	Sevelamer Hydrochloride	Sevelamer Hydrochloride
68462-446	sevelamer hydrochloride	sevelamer hydrochloride
68462-447	sevelamer hydrochloride	sevelamer hydrochloride
70748-172	Sevelamer hydrochloride	Sevelamer hydrochloride
70748-173	Sevelamer hydrochloride	Sevelamer hydrochloride