sevelamer hydrochloride

Generic: sevelamer hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sevelamer hydrochloride
Generic Name sevelamer hydrochloride
Labeler major pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
PARENTERAL
Active Ingredients

sevelamer hydrochloride 800 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7209
Product ID 0904-7209_53f9bd53-115d-48b3-b273-55e75d6a16a5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204724
Listing Expiration 2027-12-31
Marketing Start 2024-08-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047209
Hyphenated Format 0904-7209

Supplemental Identifiers

RxCUI
857224
UNII
GLS2PGI8QG

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 ANDA204724 (source: ndc)
Routes
PARENTERAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 CARTON (0904-7209-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7209-06 50 BLISTER PACK in 1 CARTON (0904-7209-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK

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": ["PARENTERAL"], "spl_id": "53f9bd53-115d-48b3-b273-55e75d6a16a5", "openfda": {"unii": ["GLS2PGI8QG"], "rxcui": ["857224"], "spl_set_id": ["0500034d-458c-42c5-918d-9acd22f0c28b"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 CARTON (0904-7209-06)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-7209-06", "marketing_start_date": "20240819"}], "brand_name": "sevelamer hydrochloride", "product_id": "0904-7209_53f9bd53-115d-48b3-b273-55e75d6a16a5", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "0904-7209", "generic_name": "sevelamer hydrochloride", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "sevelamer hydrochloride", "active_ingredients": [{"name": "SEVELAMER HYDROCHLORIDE", "strength": "800 mg/1"}], "application_number": "ANDA204724", "marketing_category": "ANDA", "marketing_start_date": "20240819", "listing_expiration_date": "20271231"}