NDC 53808-0777

Renagel

Renagel

Renagel is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Doh Central Pharmacy. The primary component is Sevelamer Hydrochloride.

• Product ID: 53808-0777_5ec67fac-794f-4ca5-a5ef-6a0cf51565e0
• NDC: 53808-0777
• Product Type: Human Prescription Drug
• Proprietary Name: Renagel
• Generic Name: Renagel
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2009-07-01
• Marketing Category: NDA / NDA
• Application Number: NDA021179
• Labeler Name: DOH CENTRAL PHARMACY
• 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 53808-0777-1

30 TABLET in 1 BLISTER PACK (53808-0777-1)

• Marketing Start Date: 2009-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53808-0777-1 [53808077701]

Renagel TABLET

• Marketing Category: NDA
• Application Number: NDA021179
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-07-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
SEVELAMER HYDROCHLORIDE	800 mg/1

OpenFDA Data

• SPL SET ID: 4a3b3dd8-9b4a-4a00-8178-eb8417195081
• Manufacturer:
  • DOH CENTRAL PHARMACY
• UNII:
  • GLS2PGI8QG
• RxNorm Concept Unique ID - RxCUI:
  • 857224
• UPC Code:
  • 0358468002112

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