sevelamer carbonate

Generic: sevelamer carbonate

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sevelamer carbonate
Generic Name sevelamer carbonate
Labeler amneal pharmaceuticals llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sevelamer carbonate 800 mg/1

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 65162-058
Product ID 65162-058_53f81fb7-7bbc-430f-a2e4-841b58e2cb7c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207288
Listing Expiration 2026-12-31
Marketing Start 2017-11-28

Pharmacologic Class

Classes
phosphate binder [epc] phosphate chelating activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65162058
Hyphenated Format 65162-058

Supplemental Identifiers

RxCUI
749206
UPC
0365162058277
UNII
9YCX42I8IU

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sevelamer carbonate (source: ndc)
Generic Name sevelamer carbonate (source: ndc)
Application Number ANDA207288 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (65162-058-03)
  • 60 TABLET, FILM COATED in 1 BOTTLE (65162-058-06)
  • 90 TABLET, FILM COATED in 1 BOTTLE (65162-058-09)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (65162-058-11)
  • 270 TABLET, FILM COATED in 1 BOTTLE (65162-058-27)
  • 500 TABLET, FILM COATED in 1 BOTTLE (65162-058-50)
source: ndc

Packages (6)

65162-058-03 30 TABLET, FILM COATED in 1 BOTTLE (65162-058-03) 65162-058-06 60 TABLET, FILM COATED in 1 BOTTLE (65162-058-06) 65162-058-09 90 TABLET, FILM COATED in 1 BOTTLE (65162-058-09) 65162-058-11 1000 TABLET, FILM COATED in 1 BOTTLE (65162-058-11) 65162-058-27 270 TABLET, FILM COATED in 1 BOTTLE (65162-058-27) 65162-058-50 500 TABLET, FILM COATED in 1 BOTTLE (65162-058-50)

Ingredients (1)

sevelamer carbonate (800 mg/1)

Linked Drug Pages (1)

Sevelamer Carbonate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "53f81fb7-7bbc-430f-a2e4-841b58e2cb7c", "openfda": {"upc": ["0365162058277"], "unii": ["9YCX42I8IU"], "rxcui": ["749206"], "spl_set_id": ["94d8cfb1-ff2a-4956-8954-17635ac505d9"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65162-058-03)", "package_ndc": "65162-058-03", "marketing_start_date": "20230713"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (65162-058-06)", "package_ndc": "65162-058-06", "marketing_start_date": "20230713"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (65162-058-09)", "package_ndc": "65162-058-09", "marketing_start_date": "20171128"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (65162-058-11)", "package_ndc": "65162-058-11", "marketing_start_date": "20171128"}, {"sample": false, "description": "270 TABLET, FILM COATED in 1 BOTTLE (65162-058-27)", "package_ndc": "65162-058-27", "marketing_start_date": "20171128"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (65162-058-50)", "package_ndc": "65162-058-50", "marketing_start_date": "20171128"}], "brand_name": "Sevelamer Carbonate", "product_id": "65162-058_53f81fb7-7bbc-430f-a2e4-841b58e2cb7c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "65162-058", "generic_name": "Sevelamer Carbonate", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sevelamer Carbonate", "active_ingredients": [{"name": "SEVELAMER CARBONATE", "strength": "800 mg/1"}], "application_number": "ANDA207288", "marketing_category": "ANDA", "marketing_start_date": "20171128", "listing_expiration_date": "20261231"}