sevelamer hydrochloride

Generic: sevelamer hydrochloride

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

sevelamer hydrochloride 800 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-242
Product ID 33342-242_6926ebbe-2d74-4d5f-b642-c1bfe3a4e305
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA206883
Listing Expiration 2026-12-31
Marketing Start 2023-05-26

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342242
Hyphenated Format 33342-242

Supplemental Identifiers

RxCUI
857216 857224
UPC
0333342242075 0333342242570 0333342241658
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 ANDA206883 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (33342-242-07)
  • 180 TABLET, FILM COATED in 1 BOTTLE (33342-242-57)
source: ndc

Packages (2)

33342-242-07 30 TABLET, FILM COATED in 1 BOTTLE (33342-242-07) 33342-242-57 180 TABLET, FILM COATED in 1 BOTTLE (33342-242-57)

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": "6926ebbe-2d74-4d5f-b642-c1bfe3a4e305", "openfda": {"upc": ["0333342242075", "0333342242570", "0333342241658"], "unii": ["GLS2PGI8QG"], "rxcui": ["857216", "857224"], "spl_set_id": ["6926ebbe-2d74-4d5f-b642-c1bfe3a4e305"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (33342-242-07)", "package_ndc": "33342-242-07", "marketing_start_date": "20230526"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (33342-242-57)", "package_ndc": "33342-242-57", "marketing_start_date": "20230526"}], "brand_name": "Sevelamer Hydrochloride", "product_id": "33342-242_6926ebbe-2d74-4d5f-b642-c1bfe3a4e305", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "33342-242", "generic_name": "Sevelamer Hydrochloride", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sevelamer Hydrochloride", "active_ingredients": [{"name": "SEVELAMER HYDROCHLORIDE", "strength": "800 mg/1"}], "application_number": "ANDA206883", "marketing_category": "ANDA", "marketing_start_date": "20230526", "listing_expiration_date": "20261231"}