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Fosrenol

lanthanum carbonate · Powder

Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Fosrenol
Generic name
lanthanum carbonate
Dosage form
Powder
Route
Oral
Marketing category
NDA · NDA
Labeler
Takeda Pharmaceuticals America, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
2
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Lanthanum Carbonate 1000 mg/1 477347 View
Lanthanum Carbonate 750 mg/1 477347 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Powder
Route of administration
Oral
Presentations
4

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Phosphate Binder [EPC] EPC All 42 members
Phosphate Chelating Activity [MoA] MoA All 42 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
204734
Application type
NDA · New Drug Application
Approval date
September 24, 2014
Sponsor
TAKEDA PHARMS USA
Products on application
2
Submissions recorded
7
Products approved under application 204734.
Product Trade name Form Strength Ingredient Status TE Flags
204734-001 FOSRENOL POWDER LANTHANUM CARBONATE Prescription — RLD
204734-002 FOSRENOL POWDER LANTHANUM CARBONATE Prescription — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
9023397 December 1, 2030 001 No December 16, 2015
8980327 December 1, 2030 001 No April 2, 2015
8980327 December 1, 2030 002 No April 2, 2015
9023397 December 1, 2030 002 No December 16, 2015

Approval history

Source: Drugs@FDA
Most recent submissions on application 204734.
Type No. Action Status Date Review
Supplement 7 Labeling Approved August 29, 2024 Standard
Supplement 6 Labeling Approved December 12, 2023 Standard
Supplement 8 Labeling Approved May 10, 2023 Standard
Supplement 5 Labeling Approved May 11, 2020 Standard
Supplement 3 Labeling Approved November 8, 2018 Standard
Supplement 1 Labeling Approved February 24, 2016 Standard
Original application 1 Type 3 - New Dosage Form Approved September 24, 2014 Standard

Review documents

  • 0 · Supplement · September 3, 2024
  • 0 · Supplement · September 2, 2024
  • 0 · Supplement · September 2, 2024
  • 0 · Supplement · December 13, 2023
  • 0 · Supplement · December 13, 2023
  • 0 · Supplement · May 11, 2023
  • 0 · Supplement · May 11, 2023
  • 0 · Supplement · May 12, 2020
  • 0 · Supplement · May 12, 2020
  • 0 · Supplement · December 7, 2018
  • 0 · Supplement · November 12, 2018
  • 0 · Supplement · February 24, 2016
  • 0 · Supplement · February 24, 2016
  • 0 · Original application · September 24, 2014
  • 0 · Original application · September 24, 2014
  • 0 · Original application · September 24, 2014
  • 0 · Original application · September 24, 2014

Adverse event reports

Source: openFDA FAERS
5,090
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: LANTHANUM CARBONATE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
54092-256-02 54092-256 Takeda Pharmaceuticals America, Inc. 9 CARTON in 1 PACKAGE (54092-256-02) / 10 POWDER in 1 CARTON (54092-256-01) September 24, 2014
54092-257-02 54092-257 Takeda Pharmaceuticals America, Inc. 9 CARTON in 1 CARTON (54092-257-02) / 10 POWDER in 1 CARTON (54092-257-01) September 24, 2014
54092-256 54092-256 Takeda Pharmaceuticals America, Inc. — September 24, 2014
54092-257 54092-257 Takeda Pharmaceuticals America, Inc. — September 24, 2014

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 12 sections on this page.