NDC 43598-478

Sevelamer Carbonate for Oral Suspension

Sevelamer Carbonate For Oral Suspension

Sevelamer Carbonate for Oral Suspension is a Oral Powder, For Suspension in the Human Prescription Drug category. It is labeled and distributed by Dr. Reddys Laboratories Inc. The primary component is Sevelamer Carbonate.

• Product ID: 43598-478_85e37025-d239-e504-38a0-c2db7ffa0100
• NDC: 43598-478
• Product Type: Human Prescription Drug
• Proprietary Name: Sevelamer Carbonate for Oral Suspension
• Generic Name: Sevelamer Carbonate For Oral Suspension
• Dosage Form: Powder, For Suspension
• Route of Administration: ORAL
• Marketing Start Date: 2018-10-25
• Marketing Category: ANDA / ANDA
• Application Number: ANDA210464
• Labeler Name: Dr. Reddys Laboratories Inc
• Substance Name: SEVELAMER CARBONATE
• Active Ingredient Strength: 800 mg/1
• Pharm Classes: Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 43598-478-90

90 PACKET in 1 CARTON (43598-478-90) > 1 POWDER, FOR SUSPENSION in 1 PACKET (43598-478-01)

• Marketing Start Date: 2018-10-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 43598-478-01 [43598047801]

Sevelamer Carbonate for Oral Suspension POWDER, FOR SUSPENSION

• Marketing Category: ANDA
• Application Number: ANDA210464
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-10-25

NDC 43598-478-90 [43598047890]

Sevelamer Carbonate for Oral Suspension POWDER, FOR SUSPENSION

• Marketing Category: ANDA
• Application Number: ANDA210464
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-10-25

Drug Details

Active Ingredients

Ingredient	Strength
SEVELAMER CARBONATE	800 mg/1

OpenFDA Data

• SPL SET ID: de172c3d-17eb-3489-35fb-370a0893b663
• Manufacturer:
  • Dr. Reddys Laboratories Inc
• UNII:
  • 9YCX42I8IU
• RxNorm Concept Unique ID - RxCUI:
  • 861375
  • 861370

Pharmacological Class

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

NDC Crossover Matching brand name "Sevelamer Carbonate for Oral Suspension" or generic name "Sevelamer Carbonate For Oral Suspension"

NDC	Brand Name	Generic Name
43598-478	Sevelamer Carbonate for Oral Suspension	Sevelamer Carbonate for Oral Suspension
43598-479	Sevelamer Carbonate for Oral Suspension	Sevelamer Carbonate for Oral Suspension