fosrenol

Generic: lanthanum carbonate

Labeler: takeda pharmaceuticals america, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name fosrenol
Generic Name lanthanum carbonate
Labeler takeda pharmaceuticals america, inc.
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

lanthanum carbonate 750 mg/1

Manufacturer
Takeda Pharmaceuticals America, Inc.

Identifiers & Regulatory

Product NDC 54092-253
Product ID 54092-253_b29f2b53-6f45-447d-afb3-297ccc4ef8db
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021468
Listing Expiration 2026-12-31
Marketing Start 2005-11-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 54092253
Hyphenated Format 54092-253

Supplemental Identifiers

RxCUI
477347 542465 602635 603112 603122 642452 1551881 1551884 1551885 1551886
UNII
490D9F069T

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 fosrenol (source: ndc)
Generic Name lanthanum carbonate (source: ndc)
Application Number NDA021468 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 750 mg/1
source: ndc
Packaging
  • 6 BOTTLE in 1 PACKAGE (54092-253-90) / 15 TABLET, CHEWABLE in 1 BOTTLE (54092-253-15)
source: ndc

Packages (1)

54092-253-90 6 BOTTLE in 1 PACKAGE (54092-253-90) / 15 TABLET, CHEWABLE in 1 BOTTLE (54092-253-15)

Ingredients (1)

lanthanum carbonate (750 mg/1)

Linked Drug Pages (1)

Fosrenol ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b29f2b53-6f45-447d-afb3-297ccc4ef8db", "openfda": {"unii": ["490D9F069T"], "rxcui": ["477347", "542465", "602635", "603112", "603122", "642452", "1551881", "1551884", "1551885", "1551886"], "spl_set_id": ["f10776b2-2c25-4343-aabe-68f302e5cb54"], "manufacturer_name": ["Takeda Pharmaceuticals America, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 BOTTLE in 1 PACKAGE (54092-253-90)  / 15 TABLET, CHEWABLE in 1 BOTTLE (54092-253-15)", "package_ndc": "54092-253-90", "marketing_start_date": "20051123"}], "brand_name": "Fosrenol", "product_id": "54092-253_b29f2b53-6f45-447d-afb3-297ccc4ef8db", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Phosphate Binder [EPC]", "Phosphate Chelating Activity [MoA]"], "product_ndc": "54092-253", "generic_name": "lanthanum carbonate", "labeler_name": "Takeda Pharmaceuticals America, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fosrenol", "active_ingredients": [{"name": "LANTHANUM CARBONATE", "strength": "750 mg/1"}], "application_number": "NDA021468", "marketing_category": "NDA", "marketing_start_date": "20051123", "listing_expiration_date": "20261231"}