Sevelamer Carbonate

Product NDC: 70518-2490
Requested package NDC: 70518-2490-0
11-digit product format: 705182490
Labeler code: 70518
Product ID: 70518-2490_c9b0275c-cb30-59ed-e053-2a95a90a01ef
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Sevelamer Carbonate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: NDA022127
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2019-12-17
Marketing end: 0000-00-00
Substance: SEVELAMER CARBONATE
Active strength: 800 mg/1
Pharmacologic classes: Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-2490	70518-2490-0	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022127-001	RENVELA	SEVELAMER CARBONATE	800MG	TABLET / ORAL		RLD	2007-10-19

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 2 · 42 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
2026-08-18 06:07:40	2026-07	N022127-001	RENVELA	800MG	TABLET / ORAL		RLD	2007-10-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022127-001	RENVELA	800MG	TABLET / ORAL	AB	RLD, RS	2007-10-19	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022127-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022127-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022127-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022127-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022127-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022127-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022127-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022127-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022127-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022127-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022127-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022127-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022127-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022127-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022127-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022127-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022127-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022127-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022127-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022127-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022127-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022127-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022127-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022127-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022127-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022127-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022127-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022127-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022127-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022127-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022127-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022127-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022127-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022127-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022127-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022127-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022127-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022127-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022127-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022127-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022127-001	7985418	2025-10-27	Drug product	2011-08-25	`cb3db0bc1861…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022127-001	NPP	2019-11-25	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N022127-001	NPP	2019-11-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022127-001	NPP	2019-11-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022127-001	NPP	2019-11-25	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-2490-0	2023-03-10	C162847	48780-1	f386c64a-17ac-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use SEVELAMER CARBONATE safely and effectively. See full prescribing information for SEVELAMER CARBONATE. SEVELAMER CARBONATE tablets, for oral use SEVELAMER CARBONATE powder, for oral suspension Initial U.S. Approval: 2000
70518-2490-0	2023-01-30	C162847	48780-1	f386c64a-17ac-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use SEVELAMER CARBONATE safely and effectively. See full prescribing information for SEVELAMER CARBONATE. SEVELAMER CARBONATE tablets, for oral use SEVELAMER CARBONATE powder, for oral suspension Initial U.S. Approval: 2000

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
Sevelamer Carbonate	SEVELAMER CARBONATE	Sanofi-Aventis U.S. LLC	3abc32fe-1bfc-4759-8f7c-36095e221b06	2025-11-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022127 application number: NDA022127
Renvela	SEVELAMER CARBONATE	Genzyme Corporation	e6328460-a57b-450b-a48c-6dcd4b476360	2025-11-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022127 application number: NDA022127

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9YCX42I8IU	SEVELAMER CARBONATE	845273-93-0	SEVELAMER CARBONATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-2490-0	70518249000	30 TABLET, FILM COATED in 1 BLISTER PACK (70518-2490-0)	2019-12-17	0000-00-00	No	No	Current