sevelamer hydrochloride

Generic: sevelamer hydrochloride

Labeler: sanofi-aventis u.s. llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name sevelamer hydrochloride
Generic Name sevelamer hydrochloride
Labeler sanofi-aventis u.s. llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sevelamer hydrochloride 800 mg/1

Manufacturer
Sanofi-Aventis U.S. LLC

Identifiers & Regulatory

Product NDC 0955-5902
Product ID 0955-5902_c080f078-1f48-42cb-9e3c-74ed2d395e1f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021179
Marketing Start 2019-02-13
Marketing End 2026-04-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09555902
Hyphenated Format 0955-5902

Supplemental Identifiers

RxCUI
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 NDA021179 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 180 TABLET, FILM COATED in 1 BOTTLE (0955-5902-18)
source: ndc

Packages (1)

0955-5902-18 180 TABLET, FILM COATED in 1 BOTTLE (0955-5902-18)

Ingredients (1)

sevelamer hydrochloride (800 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": "c080f078-1f48-42cb-9e3c-74ed2d395e1f", "openfda": {"unii": ["GLS2PGI8QG"], "rxcui": ["857224"], "spl_set_id": ["5a76bd76-a6cc-46f1-bb58-660566eaec06"], "manufacturer_name": ["Sanofi-Aventis U.S. LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (0955-5902-18)", "package_ndc": "0955-5902-18", "marketing_end_date": "20260430", "marketing_start_date": "20190213"}], "brand_name": "Sevelamer Hydrochloride", "product_id": "0955-5902_c080f078-1f48-42cb-9e3c-74ed2d395e1f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "0955-5902", "generic_name": "Sevelamer Hydrochloride", "labeler_name": "Sanofi-Aventis U.S. LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sevelamer Hydrochloride", "active_ingredients": [{"name": "SEVELAMER HYDROCHLORIDE", "strength": "800 mg/1"}], "application_number": "NDA021179", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_end_date": "20260430", "marketing_start_date": "20190213"}