sevelamer hydrochloride

Generic: sevelamer hydrochloride

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sevelamer hydrochloride
Generic Name sevelamer hydrochloride
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

sevelamer hydrochloride 800 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 70710-2058
Product ID 70710-2058_f9b9e637-d236-4bc0-afca-bbbf1b1747ab
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA218966
Listing Expiration 2026-12-31
Marketing Start 2025-03-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707102058
Hyphenated Format 70710-2058

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 ANDA218966 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 180 TABLET, FILM COATED in 1 BOTTLE (70710-2058-8)
source: ndc

Packages (1)

70710-2058-8 180 TABLET, FILM COATED in 1 BOTTLE (70710-2058-8)

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": "f9b9e637-d236-4bc0-afca-bbbf1b1747ab", "openfda": {"unii": ["GLS2PGI8QG"], "rxcui": ["857224"], "spl_set_id": ["ddecb552-5882-4e44-8fa7-37c9234dd1b9"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (70710-2058-8)", "package_ndc": "70710-2058-8", "marketing_start_date": "20250301"}], "brand_name": "Sevelamer Hydrochloride", "product_id": "70710-2058_f9b9e637-d236-4bc0-afca-bbbf1b1747ab", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "70710-2058", "generic_name": "Sevelamer Hydrochloride", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sevelamer Hydrochloride", "active_ingredients": [{"name": "SEVELAMER HYDROCHLORIDE", "strength": "800 mg/1"}], "application_number": "ANDA218966", "marketing_category": "ANDA", "marketing_start_date": "20250301", "listing_expiration_date": "20261231"}