Fosrenol

Product NDC: 54092-252
11-digit product format: 540920252
Labeler code: 54092
Product ID: 54092-252_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: 2004-10-26
Substance: LANTHANUM CARBONATE
Active strength: 500 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 44.

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.

Application-product, TE code table
Application-product	TE code
N021468-002	AB
N021468-003	AB
N021468-004	AB

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 · 176 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
2026-10-15 13:18:30	2026-09	N021468-001	FOSRENOL	EQ 250MG BASE	TABLET, CHEWABLE / ORAL			2004-10-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021468-002	FOSRENOL	EQ 500MG BASE	TABLET, CHEWABLE / ORAL	AB	RLD	2004-10-26	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021468-003	FOSRENOL	EQ 750MG BASE	TABLET, CHEWABLE / ORAL	AB	RLD	2005-11-23	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021468-004	FOSRENOL	EQ 1GM BASE	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2005-11-23	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021468-001	FOSRENOL	EQ 250MG BASE	TABLET, CHEWABLE / ORAL			2004-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021468-002	FOSRENOL	EQ 500MG BASE	TABLET, CHEWABLE / ORAL	AB	RLD	2004-10-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021468-003	FOSRENOL	EQ 750MG BASE	TABLET, CHEWABLE / ORAL	AB	RLD	2005-11-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021468-004	FOSRENOL	EQ 1GM BASE	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2005-11-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021468-001	FOSRENOL	EQ 250MG BASE	TABLET, CHEWABLE / ORAL			2004-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021468-002	FOSRENOL	EQ 500MG BASE	TABLET, CHEWABLE / ORAL	AB	RLD	2004-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021468-003	FOSRENOL	EQ 750MG BASE	TABLET, CHEWABLE / ORAL	AB	RLD	2005-11-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021468-004	FOSRENOL	EQ 1GM BASE	TABLET, CHEWABLE / ORAL	AB	RLD, RS	2005-11-23	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N021468-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021468-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021468-004	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N021468-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021468-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021468-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021468-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021468-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021468-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021468-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021468-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021468-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021468-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021468-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021468-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021468-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021468-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021468-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021468-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021468-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021468-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021468-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021468-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021468-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021468-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021468-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021468-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021468-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021468-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021468-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021468-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021468-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021468-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021468-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021468-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021468-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021468-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021468-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021468-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021468-002	AB	1	`79d66fd596c7…`

Observed Orange Book patent history#

Patent history page 4 of 7 · 280 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021468-001	7381428	2024-08-26	U-890		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021468-001	7465465	2024-08-26		Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021468-002	7381428	2024-08-26	U-890		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021468-002	7465465	2024-08-26		Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021468-003	7381428	2024-08-26	U-890		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021468-003	7465465	2024-08-26		Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021468-004	7381428	2024-08-26	U-890		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021468-004	7465465	2024-08-26		Drug product	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021468-001	7381428	2024-08-26	U-890		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021468-001	7465465	2024-08-26		Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021468-002	7381428	2024-08-26	U-890		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021468-002	7465465	2024-08-26		Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021468-003	7381428	2024-08-26	U-890		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021468-003	7465465	2024-08-26		Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021468-004	7381428	2024-08-26	U-890		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021468-004	7465465	2024-08-26		Drug product	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021468-001	7381428	2024-08-26	U-890		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021468-001	7465465	2024-08-26		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021468-002	7381428	2024-08-26	U-890		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021468-002	7465465	2024-08-26		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021468-003	7381428	2024-08-26	U-890		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021468-003	7465465	2024-08-26		Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021468-004	7381428	2024-08-26	U-890		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021468-004	7465465	2024-08-26		Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021468-001	7381428	2024-08-26	U-890		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021468-001	7465465	2024-08-26		Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021468-002	7381428	2024-08-26	U-890		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021468-002	7465465	2024-08-26		Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021468-003	7381428	2024-08-26	U-890		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021468-003	7465465	2024-08-26		Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021468-004	7381428	2024-08-26	U-890		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021468-004	7465465	2024-08-26		Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021468-001	7381428	2024-08-26	U-890		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021468-001	7465465	2024-08-26		Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021468-002	7381428	2024-08-26	U-890		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021468-002	7465465	2024-08-26		Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021468-003	7381428	2024-08-26	U-890		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021468-003	7465465	2024-08-26		Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021468-004	7381428	2024-08-26	U-890		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021468-004	7465465	2024-08-26		Drug product	`3f01610625f2…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Fosrenol
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LANTHANUM CARBONATE	500 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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
f10776b2-2c25-4343-aabe-68f302e5cb54	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cd999b70-ef95-1812-9f06-f589ecff7593	Product name	5	20251216

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54092-252-45	Fosrenol	45 in 1 BOTTLE	TABLET, CHEWABLE	45		58
54092-252-90	Fosrenol	2 in 1 PACKAGE	TABLET, CHEWABLE	2		58

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54092-252-45	EA - Each	54092-252	b282d18a-0ea6-49f4-9604-90f1f1568bc4	1	2012-07-24
54092-252-90	EA - Each	54092-252	3074ba73-ac12-4a1e-94f8-89da7eee738e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LANTHANUM CARBONATE	ACTIVE INGREDIENT	490D9F069T	FOSRENOL (LANTHANUM CARBONATE) TABLET, CHEWABLE FOSRENOL (LANTHANUM CARBONATE) POWDER [SHIRE US MANUFACTURING INC.]	39
LANTHANUM CATION (3+)	ACTIVE MOIETY	O7FU5X12W5	FOSRENOL (LANTHANUM CARBONATE) TABLET, CHEWABLE FOSRENOL (LANTHANUM CARBONATE) POWDER [SHIRE US MANUFACTURING INC.]	39
DEXTRATES	INACTIVE INGREDIENT	G263MI44RU	FOSRENOL (LANTHANUM CARBONATE) TABLET, CHEWABLE FOSRENOL (LANTHANUM CARBONATE) POWDER [SHIRE US MANUFACTURING INC.]	39
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FOSRENOL (LANTHANUM CARBONATE) TABLET, CHEWABLE FOSRENOL (LANTHANUM CARBONATE) POWDER [SHIRE US MANUFACTURING INC.]	39
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FOSRENOL (LANTHANUM CARBONATE) TABLET, CHEWABLE FOSRENOL (LANTHANUM CARBONATE) POWDER [SHIRE US MANUFACTURING INC.]	39

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54092-252	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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lanthanum carbonate	LANTHANUM CARBONATE	Prasco Laboratories	bb263fe8-2bdf-4dba-807f-194f54a73654	2025-12-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021468 application number: NDA021468
Fosrenol	LANTHANUM CARBONATE	Takeda Pharmaceuticals America, Inc.	f10776b2-2c25-4343-aabe-68f302e5cb54	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021468 application number: NDA021468 ndc (product): 54092-252

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
490D9F069T	LANTHANUM CARBONATE	54451-24-0	LANTHANUM CARBONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
603112	FOSRENOL 1000 MG Chewable Tablet	PSN	f10776b2-2c25-4343-aabe-68f302e5cb54	58
1551884	Fosrenol 1000 MG Oral Powder	PSN	f10776b2-2c25-4343-aabe-68f302e5cb54	58
542465	FOSRENOL 500 MG Chewable Tablet	PSN	f10776b2-2c25-4343-aabe-68f302e5cb54	58
603122	FOSRENOL 750 MG Chewable Tablet	PSN	f10776b2-2c25-4343-aabe-68f302e5cb54	58
1551886	Fosrenol 750 MG Oral Powder	PSN	f10776b2-2c25-4343-aabe-68f302e5cb54	58
602635	lanthanum carbonate 1000 MG Chewable Tablet	PSN	f10776b2-2c25-4343-aabe-68f302e5cb54	58
1551881	lanthanum carbonate 1000 MG Oral Powder	PSN	f10776b2-2c25-4343-aabe-68f302e5cb54	58
477347	lanthanum carbonate 500 MG Chewable Tablet	PSN	f10776b2-2c25-4343-aabe-68f302e5cb54	58
642452	lanthanum carbonate 750 MG Chewable Tablet	PSN	f10776b2-2c25-4343-aabe-68f302e5cb54	58
1551885	lanthanum carbonate 750 MG Oral Powder	PSN	f10776b2-2c25-4343-aabe-68f302e5cb54	58
603112	lanthanum carbonate 1000 MG Chewable Tablet [Fosrenol]	SBD	f10776b2-2c25-4343-aabe-68f302e5cb54	58
1551884	lanthanum carbonate 1000 MG Oral Powder [Fosrenol]	SBD	f10776b2-2c25-4343-aabe-68f302e5cb54	58
542465	lanthanum carbonate 500 MG Chewable Tablet [Fosrenol]	SBD	f10776b2-2c25-4343-aabe-68f302e5cb54	58
603122	lanthanum carbonate 750 MG Chewable Tablet [Fosrenol]	SBD	f10776b2-2c25-4343-aabe-68f302e5cb54	58
1551886	lanthanum carbonate 750 MG Oral Powder [Fosrenol]	SBD	f10776b2-2c25-4343-aabe-68f302e5cb54	58
602635	lanthanum carbonate 1000 MG Chewable Tablet	SCD	f10776b2-2c25-4343-aabe-68f302e5cb54	58
1551881	lanthanum carbonate 1000 MG Oral Powder	SCD	f10776b2-2c25-4343-aabe-68f302e5cb54	58
477347	lanthanum carbonate 500 MG Chewable Tablet	SCD	f10776b2-2c25-4343-aabe-68f302e5cb54	58
642452	lanthanum carbonate 750 MG Chewable Tablet	SCD	f10776b2-2c25-4343-aabe-68f302e5cb54	58
1551885	lanthanum carbonate 750 MG Oral Powder	SCD	f10776b2-2c25-4343-aabe-68f302e5cb54	58
603112	Fosrenol 1,000 MG Chewable Tablet	SY	f10776b2-2c25-4343-aabe-68f302e5cb54	58
1551884	Fosrenol 1000 MG Oral Powder	SY	f10776b2-2c25-4343-aabe-68f302e5cb54	58
542465	Fosrenol 500 MG Chewable Tablet	SY	f10776b2-2c25-4343-aabe-68f302e5cb54	58
603122	Fosrenol 750 MG Chewable Tablet	SY	f10776b2-2c25-4343-aabe-68f302e5cb54	58
1551886	Fosrenol 750 MG Oral Powder	SY	f10776b2-2c25-4343-aabe-68f302e5cb54	58

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54092-252-45	54092025245	45 in 1 BOTTLE						Historical
54092-252-90	54092025290	2 BOTTLE in 1 PACKAGE (54092-252-90) / 45 TABLET, CHEWABLE in 1 BOTTLE (54092-252-45)	2 bottle	2004-10-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fosrenol	Takeda Pharmaceuticals America, Inc. \| Patheon Manufacturing Services LLC \| Element Materials Technology Pharma US LLC \| Reading Scientific Services Ltd (RSSL) \| Triclinic Labs \| Microbac Laboratories, Inc. \| Catalent Germany Schorndorf GmbH \| BCM Ltd \| Reckitt Benckiser Healthcare International Ltd.	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	58