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 POWDER, FOR SUSPENSION
Routes
ORAL
Active Ingredients

sevelamer carbonate 2400 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-931
Product ID 65862-931_e8c6db3c-3509-4033-8161-555236328bed
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207624
Listing Expiration 2026-12-31
Marketing Start 2017-06-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862931
Hyphenated Format 65862-931

Supplemental Identifiers

RxCUI
861370 861375
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 ANDA207624 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 2400 mg/1
source: ndc
Packaging
  • 90 POUCH in 1 CARTON (65862-931-90) / 1 POWDER, FOR SUSPENSION in 1 POUCH (65862-931-08)
source: ndc

Packages (1)

65862-931-90 90 POUCH in 1 CARTON (65862-931-90) / 1 POWDER, FOR SUSPENSION in 1 POUCH (65862-931-08)

Ingredients (1)

sevelamer carbonate (2400 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": "e8c6db3c-3509-4033-8161-555236328bed", "openfda": {"unii": ["9YCX42I8IU"], "rxcui": ["861370", "861375"], "spl_set_id": ["ea201bff-cdfb-4304-bdb1-d05c1dac2677"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 POUCH in 1 CARTON (65862-931-90)  / 1 POWDER, FOR SUSPENSION in 1 POUCH (65862-931-08)", "package_ndc": "65862-931-90", "marketing_start_date": "20170613"}], "brand_name": "SEVELAMER CARBONATE", "product_id": "65862-931_e8c6db3c-3509-4033-8161-555236328bed", "dosage_form": "POWDER, FOR SUSPENSION", "pharm_class": ["Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "65862-931", "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": "2400 mg/1"}], "application_number": "ANDA207624", "marketing_category": "ANDA", "marketing_start_date": "20170613", "listing_expiration_date": "20261231"}