sevelamer carbonate

Generic: sevelamer carbonate

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

sevelamer carbonate 800 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-215
Product ID 33342-215_2b6f40af-8d33-4bd1-9eb9-4ae0bdf8bbcb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206100
Listing Expiration 2026-12-31
Marketing Start 2023-04-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342215
Hyphenated Format 33342-215

Supplemental Identifiers

RxCUI
749206
UPC
0333342215581
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 ANDA206100 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 270 TABLET, FILM COATED in 1 BOTTLE (33342-215-58)
source: ndc

Packages (1)

33342-215-58 270 TABLET, FILM COATED in 1 BOTTLE (33342-215-58)

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": "2b6f40af-8d33-4bd1-9eb9-4ae0bdf8bbcb", "openfda": {"upc": ["0333342215581"], "unii": ["9YCX42I8IU"], "rxcui": ["749206"], "spl_set_id": ["4c927d50-34a6-499b-b1c2-924d4eb73987"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "270 TABLET, FILM COATED in 1 BOTTLE (33342-215-58)", "package_ndc": "33342-215-58", "marketing_start_date": "20230419"}], "brand_name": "Sevelamer Carbonate", "product_id": "33342-215_2b6f40af-8d33-4bd1-9eb9-4ae0bdf8bbcb", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "33342-215", "generic_name": "Sevelamer Carbonate", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sevelamer Carbonate", "active_ingredients": [{"name": "SEVELAMER CARBONATE", "strength": "800 mg/1"}], "application_number": "ANDA206100", "marketing_category": "ANDA", "marketing_start_date": "20230419", "listing_expiration_date": "20261231"}