Home NDC 54092-254 Fosrenol
Product NDC 54092-254
11-digit product format 540920254
Labeler code 54092
Product ID 54092-254_b29f2b53-6f45-447d-afb3-297ccc4ef8db
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name lanthanum carbonate
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Takeda Pharmaceuticals America, Inc.
Application NDA021468
Marketing category NDA
Marketing start 2005-11-23
Substance LANTHANUM CARBONATE
Active strength 1000 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 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021468-001 FOSRENOL LANTHANUM CARBONATE EQ 250MG BASE TABLET, CHEWABLE / ORAL 2004-10-26 N021468-002 FOSRENOL LANTHANUM CARBONATE EQ 500MG BASE TABLET, CHEWABLE / ORAL AB RLD 2004-10-26 N021468-003 FOSRENOL LANTHANUM CARBONATE EQ 750MG BASE TABLET, CHEWABLE / ORAL AB RLD 2005-11-23 N021468-004 FOSRENOL LANTHANUM CARBONATE EQ 1GM BASE TABLET, CHEWABLE / ORAL AB RLD, RS 2005-11-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 5 · 164 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 N021468-001 FOSRENOL EQ 250MG BASE TABLET, CHEWABLE / ORAL 2004-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021468-002 FOSRENOL EQ 500MG BASE TABLET, CHEWABLE / ORAL AB RLD 2004-10-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021468-003 FOSRENOL EQ 750MG BASE TABLET, CHEWABLE / ORAL AB RLD 2005-11-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021468-004 FOSRENOL EQ 1GM BASE TABLET, CHEWABLE / ORAL AB RLD, RS 2005-11-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021468-001 FOSRENOL EQ 250MG BASE TABLET, CHEWABLE / ORAL 2004-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021468-002 FOSRENOL EQ 500MG BASE TABLET, CHEWABLE / ORAL AB RLD 2004-10-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021468-003 FOSRENOL EQ 750MG BASE TABLET, CHEWABLE / ORAL AB RLD 2005-11-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021468-004 FOSRENOL EQ 1GM BASE TABLET, CHEWABLE / ORAL AB RLD, RS 2005-11-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021468-001 FOSRENOL EQ 250MG BASE TABLET, CHEWABLE / ORAL 2004-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021468-002 FOSRENOL EQ 500MG BASE TABLET, CHEWABLE / ORAL AB RLD 2004-10-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021468-003 FOSRENOL EQ 750MG BASE TABLET, CHEWABLE / ORAL AB RLD 2005-11-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021468-004 FOSRENOL EQ 1GM BASE TABLET, CHEWABLE / ORAL AB RLD, RS 2005-11-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021468-001 FOSRENOL EQ 250MG BASE TABLET, CHEWABLE / ORAL 2004-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021468-002 FOSRENOL EQ 500MG BASE TABLET, CHEWABLE / ORAL AB RLD 2004-10-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021468-003 FOSRENOL EQ 750MG BASE TABLET, CHEWABLE / ORAL AB RLD 2005-11-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021468-004 FOSRENOL EQ 1GM BASE TABLET, CHEWABLE / ORAL AB RLD, RS 2005-11-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021468-001 FOSRENOL EQ 250MG BASE TABLET, CHEWABLE / ORAL 2004-10-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021468-002 FOSRENOL EQ 500MG BASE TABLET, CHEWABLE / ORAL AB RLD 2004-10-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021468-003 FOSRENOL EQ 750MG BASE TABLET, CHEWABLE / ORAL AB RLD 2005-11-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021468-004 FOSRENOL EQ 1GM BASE TABLET, CHEWABLE / ORAL AB RLD, RS 2005-11-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021468-001 FOSRENOL EQ 250MG BASE TABLET, CHEWABLE / ORAL 2004-10-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021468-002 FOSRENOL EQ 500MG BASE TABLET, CHEWABLE / ORAL AB RLD 2004-10-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021468-003 FOSRENOL EQ 750MG BASE TABLET, CHEWABLE / ORAL AB RLD 2005-11-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021468-004 FOSRENOL EQ 1GM BASE TABLET, CHEWABLE / ORAL AB RLD, RS 2005-11-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021468-001 FOSRENOL EQ 250MG BASE TABLET, CHEWABLE / ORAL 2004-10-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021468-002 FOSRENOL EQ 500MG BASE TABLET, CHEWABLE / ORAL AB RLD 2004-10-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021468-003 FOSRENOL EQ 750MG BASE TABLET, CHEWABLE / ORAL AB RLD 2005-11-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021468-004 FOSRENOL EQ 1GM BASE TABLET, CHEWABLE / ORAL AB RLD, RS 2005-11-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021468-001 FOSRENOL EQ 250MG BASE TABLET, CHEWABLE / ORAL 2004-10-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021468-002 FOSRENOL EQ 500MG BASE TABLET, CHEWABLE / ORAL AB RLD 2004-10-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021468-003 FOSRENOL EQ 750MG BASE TABLET, CHEWABLE / ORAL AB RLD 2005-11-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021468-004 FOSRENOL EQ 1GM BASE TABLET, CHEWABLE / ORAL AB RLD, RS 2005-11-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021468-001 FOSRENOL EQ 250MG BASE TABLET, CHEWABLE / ORAL 2004-10-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021468-002 FOSRENOL EQ 500MG BASE TABLET, CHEWABLE / ORAL AB RLD 2004-10-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021468-003 FOSRENOL EQ 750MG BASE TABLET, CHEWABLE / ORAL AB RLD 2005-11-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021468-004 FOSRENOL EQ 1GM BASE TABLET, CHEWABLE / ORAL AB RLD, RS 2005-11-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021468-001 FOSRENOL EQ 250MG BASE TABLET, CHEWABLE / ORAL 2004-10-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021468-002 FOSRENOL EQ 500MG BASE TABLET, CHEWABLE / ORAL AB RLD 2004-10-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021468-003 FOSRENOL EQ 750MG BASE TABLET, CHEWABLE / ORAL AB RLD 2005-11-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021468-004 FOSRENOL EQ 1GM BASE TABLET, CHEWABLE / ORAL AB RLD, RS 2005-11-23 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Observed Orange Book patent history# Patent history page 1 of 7 · 280 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021468-001 7381428 2024-08-26 U-890 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021468-001 7465465 2024-08-26 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021468-002 7381428 2024-08-26 U-890 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021468-002 7465465 2024-08-26 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021468-003 7381428 2024-08-26 U-890 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021468-003 7465465 2024-08-26 Drug product 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021468-004 7381428 2024-08-26 U-890 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021468-004 7465465 2024-08-26 Drug product 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021468-001 7381428 2024-08-26 U-890 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021468-001 7465465 2024-08-26 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021468-002 7381428 2024-08-26 U-890 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021468-002 7465465 2024-08-26 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021468-003 7381428 2024-08-26 U-890 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021468-003 7465465 2024-08-26 Drug product 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021468-004 7381428 2024-08-26 U-890 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021468-004 7465465 2024-08-26 Drug product 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021468-001 7381428 2024-08-26 U-890 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021468-001 7465465 2024-08-26 Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021468-002 7381428 2024-08-26 U-890 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021468-002 7465465 2024-08-26 Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021468-003 7381428 2024-08-26 U-890 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021468-003 7465465 2024-08-26 Drug product 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021468-004 7381428 2024-08-26 U-890 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021468-004 7465465 2024-08-26 Drug product 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021468-001 7381428 2024-08-26 U-890 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021468-001 7465465 2024-08-26 Drug product d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021468-002 7381428 2024-08-26 U-890 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021468-002 7465465 2024-08-26 Drug product d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021468-003 7381428 2024-08-26 U-890 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021468-003 7465465 2024-08-26 Drug product d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021468-004 7381428 2024-08-26 U-890 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021468-004 7465465 2024-08-26 Drug product d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021468-001 7381428 2024-08-26 U-890 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021468-001 7465465 2024-08-26 Drug product d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021468-002 7381428 2024-08-26 U-890 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021468-002 7465465 2024-08-26 Drug product d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021468-003 7381428 2024-08-26 U-890 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021468-003 7465465 2024-08-26 Drug product d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021468-004 7381428 2024-08-26 U-890 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021468-004 7465465 2024-08-26 Drug product d06236e962d9…
Additional Listing Data#
Finished product Yes
Brand name base Fosrenol
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LANTHANUM CARBONATE 1000 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 54092-254-10 Fosrenol 10 in 1 BOTTLE TABLET, CHEWABLE 10 58 54092-254-90 Fosrenol 9 in 1 PACKAGE TABLET, CHEWABLE 9 58
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54092-254 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 · 2 matching rows.
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 54092-254-10 54092025410 10 in 1 BOTTLE Historical 54092-254-90 54092025490 9 BOTTLE in 1 PACKAGE (54092-254-90) / 10 TABLET, CHEWABLE in 1 BOTTLE (54092-254-10) 9 bottle 2005-11-23 0000-00-00 No No Current