sevelamer hydrochloride

Generic: sevelamer hydrochloride

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

Drug Facts

Product Profile

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

sevelamer hydrochloride 400 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-087
Product ID 59651-087_7a6f6abf-8a91-423e-8f2f-de1b3a019e7b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212599
Listing Expiration 2026-12-31
Marketing Start 2023-07-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651087
Hyphenated Format 59651-087

Supplemental Identifiers

RxCUI
857216 857224
UNII
GLS2PGI8QG

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 hydrochloride (source: ndc)
Generic Name sevelamer hydrochloride (source: ndc)
Application Number ANDA212599 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 360 TABLET, FILM COATED in 1 BOTTLE (59651-087-36)
source: ndc

Packages (1)

59651-087-36 360 TABLET, FILM COATED in 1 BOTTLE (59651-087-36)

Ingredients (1)

sevelamer hydrochloride (400 mg/1)

Linked Drug Pages (1)

SEVELAMER HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "7a6f6abf-8a91-423e-8f2f-de1b3a019e7b", "openfda": {"unii": ["GLS2PGI8QG"], "rxcui": ["857216", "857224"], "spl_set_id": ["d8729e42-dbbd-4954-9ce0-298743a15a06"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "360 TABLET, FILM COATED in 1 BOTTLE (59651-087-36)", "package_ndc": "59651-087-36", "marketing_start_date": "20230711"}], "brand_name": "SEVELAMER HYDROCHLORIDE", "product_id": "59651-087_7a6f6abf-8a91-423e-8f2f-de1b3a019e7b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "59651-087", "generic_name": "SEVELAMER HYDROCHLORIDE", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SEVELAMER HYDROCHLORIDE", "active_ingredients": [{"name": "SEVELAMER HYDROCHLORIDE", "strength": "400 mg/1"}], "application_number": "ANDA212599", "marketing_category": "ANDA", "marketing_start_date": "20230711", "listing_expiration_date": "20261231"}