Home NDC 54092-256 Fosrenol
Product NDC 54092-256
11-digit product format 540920256
Labeler code 54092
Product ID 54092-256_b29f2b53-6f45-447d-afb3-297ccc4ef8db
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lanthanum carbonate
Dosage form POWDER
Route ORAL
Labeler Takeda Pharmaceuticals America, Inc.
Application NDA204734
Marketing category NDA
Marketing start 2014-09-24
Substance LANTHANUM CARBONATE
Active strength 750 mg/1
Pharmacologic classes Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N204734-001 FOSRENOL LANTHANUM CARBONATE EQ 750MG BASE POWDER / ORAL RLD 2014-09-24 N204734-002 FOSRENOL LANTHANUM CARBONATE EQ 1GM BASE POWDER / ORAL RLD, RS 2014-09-24
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N204734-001 8980327 2030-12-01 Drug product 2015-04-02 N204734-001 9023397 2030-12-01 Drug product 2015-12-16 N204734-002 8980327 2030-12-01 Drug product 2015-04-02 N204734-002 9023397 2030-12-01 Drug product 2015-12-16
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N204734-001 FOSRENOL EQ 750MG BASE POWDER / ORAL RLD 2014-09-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204734-002 FOSRENOL EQ 1GM BASE POWDER / ORAL RLD, RS 2014-09-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204734-001 FOSRENOL EQ 750MG BASE POWDER / ORAL RLD 2014-09-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204734-002 FOSRENOL EQ 1GM BASE POWDER / ORAL RLD, RS 2014-09-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204734-001 FOSRENOL EQ 750MG BASE POWDER / ORAL RLD 2014-09-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204734-002 FOSRENOL EQ 1GM BASE POWDER / ORAL RLD, RS 2014-09-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204734-001 FOSRENOL EQ 750MG BASE POWDER / ORAL RLD 2014-09-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204734-002 FOSRENOL EQ 1GM BASE POWDER / ORAL RLD, RS 2014-09-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204734-001 FOSRENOL EQ 750MG BASE POWDER / ORAL RLD 2014-09-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204734-002 FOSRENOL EQ 1GM BASE POWDER / ORAL RLD, RS 2014-09-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204734-001 FOSRENOL EQ 750MG BASE POWDER / ORAL RLD 2014-09-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204734-002 FOSRENOL EQ 1GM BASE POWDER / ORAL RLD, RS 2014-09-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204734-001 FOSRENOL EQ 750MG BASE POWDER / ORAL RLD 2014-09-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204734-002 FOSRENOL EQ 1GM BASE POWDER / ORAL RLD, RS 2014-09-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204734-001 FOSRENOL EQ 750MG BASE POWDER / ORAL RLD 2014-09-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204734-002 FOSRENOL EQ 1GM BASE POWDER / ORAL RLD, RS 2014-09-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204734-001 FOSRENOL EQ 750MG BASE POWDER / ORAL RLD 2014-09-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204734-002 FOSRENOL EQ 1GM BASE POWDER / ORAL RLD, RS 2014-09-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N204734-001 FOSRENOL EQ 750MG BASE POWDER / ORAL RLD 2014-09-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N204734-002 FOSRENOL EQ 1GM BASE POWDER / ORAL RLD, RS 2014-09-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204734-001 FOSRENOL EQ 750MG BASE POWDER / ORAL RLD 2014-09-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N204734-002 FOSRENOL EQ 1GM BASE POWDER / ORAL RLD, RS 2014-09-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204734-001 FOSRENOL EQ 750MG BASE POWDER / ORAL RLD 2014-09-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N204734-002 FOSRENOL EQ 1GM BASE POWDER / ORAL RLD, RS 2014-09-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204734-001 FOSRENOL EQ 750MG BASE POWDER / ORAL RLD 2014-09-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N204734-002 FOSRENOL EQ 1GM BASE POWDER / ORAL RLD, RS 2014-09-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N204734-001 FOSRENOL EQ 750MG BASE POWDER / ORAL RLD 2014-09-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N204734-002 FOSRENOL EQ 1GM BASE POWDER / ORAL RLD, RS 2014-09-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204734-001 FOSRENOL EQ 750MG BASE POWDER / ORAL RLD 2014-09-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N204734-002 FOSRENOL EQ 1GM BASE POWDER / ORAL RLD, RS 2014-09-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N204734-001 FOSRENOL EQ 750MG BASE POWDER / ORAL RLD 2014-09-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N204734-002 FOSRENOL EQ 1GM BASE POWDER / ORAL RLD, RS 2014-09-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N204734-001 FOSRENOL EQ 750MG BASE POWDER / ORAL RLD 2014-09-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N204734-002 FOSRENOL EQ 1GM BASE POWDER / ORAL RLD, RS 2014-09-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N204734-001 FOSRENOL EQ 750MG BASE POWDER / ORAL RLD 2014-09-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N204734-002 FOSRENOL EQ 1GM BASE POWDER / ORAL RLD, RS 2014-09-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N204734-001 FOSRENOL EQ 750MG BASE POWDER / ORAL RLD 2014-09-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N204734-002 FOSRENOL EQ 1GM BASE POWDER / ORAL RLD, RS 2014-09-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N204734-001 FOSRENOL EQ 750MG BASE POWDER / ORAL RLD 2014-09-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N204734-002 FOSRENOL EQ 1GM BASE POWDER / ORAL RLD, RS 2014-09-24 782e0a99824c…
Observed Orange Book patent history# Patent history page 1 of 6 · 234 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N204734-001 8980327 2030-12-01 Drug product 2015-04-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204734-001 9023397 2030-12-01 Drug product 2015-12-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204734-002 8980327 2030-12-01 Drug product 2015-04-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N204734-002 9023397 2030-12-01 Drug product 2015-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204734-001 8980327 2030-12-01 Drug product 2015-04-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204734-001 9023397 2030-12-01 Drug product 2015-12-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204734-002 8980327 2030-12-01 Drug product 2015-04-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N204734-002 9023397 2030-12-01 Drug product 2015-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N204734-001 8980327 2030-12-01 Drug product 2015-04-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204734-001 9023397 2030-12-01 Drug product 2015-12-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204734-002 8980327 2030-12-01 Drug product 2015-04-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N204734-002 9023397 2030-12-01 Drug product 2015-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204734-001 8980327 2030-12-01 Drug product 2015-04-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204734-001 9023397 2030-12-01 Drug product 2015-12-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204734-002 8980327 2030-12-01 Drug product 2015-04-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N204734-002 9023397 2030-12-01 Drug product 2015-12-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204734-001 8980327 2030-12-01 Drug product 2015-04-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204734-001 9023397 2030-12-01 Drug product 2015-12-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204734-002 8980327 2030-12-01 Drug product 2015-04-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N204734-002 9023397 2030-12-01 Drug product 2015-12-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204734-001 7465465 2024-08-26 Drug product 2014-10-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204734-001 8980327 2030-12-01 Drug product 2015-04-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204734-001 9023397 2030-12-01 Drug product 2015-12-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204734-002 7465465 2024-08-26 Drug product 2014-10-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204734-002 8980327 2030-12-01 Drug product 2015-04-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N204734-002 9023397 2030-12-01 Drug product 2015-12-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204734-001 7465465 2024-08-26 Drug product 2014-10-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204734-001 8980327 2030-12-01 Drug product 2015-04-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204734-001 9023397 2030-12-01 Drug product 2015-12-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204734-002 7465465 2024-08-26 Drug product 2014-10-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204734-002 8980327 2030-12-01 Drug product 2015-04-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N204734-002 9023397 2030-12-01 Drug product 2015-12-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204734-001 7465465 2024-08-26 Drug product 2014-10-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204734-001 8980327 2030-12-01 Drug product 2015-04-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204734-001 9023397 2030-12-01 Drug product 2015-12-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204734-002 7465465 2024-08-26 Drug product 2014-10-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204734-002 8980327 2030-12-01 Drug product 2015-04-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N204734-002 9023397 2030-12-01 Drug product 2015-12-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204734-001 7465465 2024-08-26 Drug product 2014-10-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N204734-001 8980327 2030-12-01 Drug product 2015-04-02 d8e5a09893c0…
Additional Listing Data#
Finished product Yes
Brand name base Fosrenol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LANTHANUM CARBONATE 750 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 490D9F069T Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 10 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 477347 Internal RxNorm lookup 542465 Internal RxNorm lookup 602635 Internal RxNorm lookup 603112 Internal RxNorm lookup 603122 Internal RxNorm lookup 642452 Internal RxNorm lookup 1551881 Internal RxNorm lookup 1551884 Internal RxNorm lookup 1551885 Internal RxNorm lookup 1551886 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54092-256-01 Fosrenol 10 in 1 CARTON POWDER 10 58 54092-256-02 Fosrenol 9 in 1 PACKAGE POWDER 9 58
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54092-256 FOSRENOL (LANTHANUM CARBONATE) TABLET, CHEWABLE FOSRENOL (LANTHANUM CARBONATE) POWDER [TAKEDA PHARMACEUTICALS AMERICA, INC.] 58 Current NDC, Legacy NDC, 2 package rows 20250406_f10776b2-2c25-4343-aabe-68f302e5cb54.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Fosrenol LANTHANUM CARBONATE Takeda Pharmaceuticals America, Inc. f10776b2-2c25-4343-aabe-68f302e5cb54 2024-12-31 Warnings, Adverse reactions Exact identifier application applno (NDA): 204734 application number: NDA204734 ndc (product): 54092-256
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54092-256-01 54092025601 10 in 1 CARTON Historical 54092-256-02 54092025602 9 CARTON in 1 PACKAGE (54092-256-02) / 10 POWDER in 1 CARTON (54092-256-01) 9 carton 2014-09-24 0000-00-00 No No Current