sevelamer carbonate

Generic: sevelamer carbonate

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

sevelamer carbonate 800 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-921
Product ID 65862-921_761597e6-1a2e-48e7-b657-c3fa781b4f6b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207179
Listing Expiration 2026-12-31
Marketing Start 2017-07-17

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862921
Hyphenated Format 65862-921

Supplemental Identifiers

RxCUI
749206
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 ANDA207179 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 180 TABLET, FILM COATED in 1 BOTTLE (65862-921-18)
  • 270 TABLET, FILM COATED in 1 BOTTLE (65862-921-27)
  • 30 TABLET, FILM COATED in 1 BOTTLE (65862-921-30)
source: ndc

Packages (3)

65862-921-18 180 TABLET, FILM COATED in 1 BOTTLE (65862-921-18) 65862-921-27 270 TABLET, FILM COATED in 1 BOTTLE (65862-921-27) 65862-921-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-921-30)

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": "761597e6-1a2e-48e7-b657-c3fa781b4f6b", "openfda": {"unii": ["9YCX42I8IU"], "rxcui": ["749206"], "spl_set_id": ["ab0cd45f-0c4b-4ce7-bf8e-5f98d43feaab"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (65862-921-18)", "package_ndc": "65862-921-18", "marketing_start_date": "20170717"}, {"sample": false, "description": "270 TABLET, FILM COATED in 1 BOTTLE (65862-921-27)", "package_ndc": "65862-921-27", "marketing_start_date": "20170717"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-921-30)", "package_ndc": "65862-921-30", "marketing_start_date": "20170717"}], "brand_name": "Sevelamer Carbonate", "product_id": "65862-921_761597e6-1a2e-48e7-b657-c3fa781b4f6b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "65862-921", "generic_name": "Sevelamer Carbonate", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sevelamer Carbonate", "active_ingredients": [{"name": "SEVELAMER CARBONATE", "strength": "800 mg/1"}], "application_number": "ANDA207179", "marketing_category": "ANDA", "marketing_start_date": "20170717", "listing_expiration_date": "20261231"}