Renvela

Product NDC: 58468-0131
11-digit product format: 584680131
Labeler code: 58468
Product ID: 58468-0131_cb4453a2-c47b-4352-839f-f022ac67368e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: SEVELAMER CARBONATE
Dosage form: POWDER, FOR SUSPENSION
Route: ORAL
Labeler: Genzyme Corporation
Application: NDA022318
Marketing category: NDA
Marketing start: 2009-08-12
Substance: SEVELAMER CARBONATE
Active strength: 2400 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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	58468-0131	58468-0131-4	D	Discontinued by firm		2026-08-17
excluded package	package	58468-0131	58468-0131-5	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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	58468-0131-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	58468-0131-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	58468-0131-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	58468-0131-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	58468-0131-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	58468-0131-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	58468-0131-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	58468-0131-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	58468-0131-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	58468-0131-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	58468-0131-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	58468-0131-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	58468-0131-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	58468-0131-5	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	58468-0131-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	58468-0131-5	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	58468-0131-4	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	58468-0131-5	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	58468-0131-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	58468-0131-5	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	58468-0131-4	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	58468-0131-5	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	58468-0131-4	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	58468-0131-5	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

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
N022318-001	RENVELA	SEVELAMER CARBONATE	800MG/PACKET	FOR SUSPENSION / ORAL		RLD	2009-08-12
N022318-002	RENVELA	SEVELAMER CARBONATE	2.4GM/PACKET	FOR SUSPENSION / ORAL		RLD	2009-02-18

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022318-001	9095509	2030-12-06		Drug product	2016-01-13
N022318-002	9095509	2030-12-06		Drug product	2016-01-13

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 · 84 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	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL		RLD	2009-08-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL		RLD	2009-02-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022318-001	RENVELA	800MG/PACKET	FOR SUSPENSION / ORAL	AB	RLD	2009-08-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022318-002	RENVELA	2.4GM/PACKET	FOR SUSPENSION / ORAL	AB	RLD, RS	2009-02-18	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022318-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022318-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022318-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022318-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022318-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022318-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022318-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022318-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022318-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022318-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022318-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022318-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022318-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022318-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022318-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022318-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022318-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022318-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022318-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022318-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022318-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022318-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022318-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022318-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022318-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022318-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022318-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022318-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022318-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022318-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022318-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022318-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022318-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022318-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022318-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022318-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022318-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022318-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022318-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022318-002	AB	1	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022318-001	9095509	2030-12-06	Drug product	2016-01-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022318-002	9095509	2030-12-06	Drug product	2016-01-13	`bb7c543d1eb4…`

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	N022318-001	NPP	2019-11-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022318-002	NPP	2019-11-25	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N022318-001	NPP	2019-11-25	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022318-002	NPP	2019-11-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022318-001	NPP	2019-11-25	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022318-002	NPP	2019-11-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022318-001	NPP	2019-11-25	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022318-002	NPP	2019-11-25	`ea99ee380514…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SEVELAMER CARBONATE	2400 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9YCX42I8IU	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
749206	Internal RxNorm lookup
749210	Internal RxNorm lookup
861370	Internal RxNorm lookup
861373	Internal RxNorm lookup
861375	Internal RxNorm lookup
861377	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
e6328460-a57b-450b-a48c-6dcd4b476360	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5085f16b-f856-182d-a646-425b62d3f565	Product name	6	20251118
86e7ef73-ca63-701e-e952-6c80aa5122b8	Product name	9	20210309

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
58468-0131-1	Renvela	1 in 1 PACKET	POWDER, FOR SUSPENSION	1	47
58468-0131-2	Renvela	90 in 1 CARTON	POWDER, FOR SUSPENSION	90	47
58468-0131-3	Renvela	1 in 1 PACKET	POWDER, FOR SUSPENSION	1	47
58468-0131-4	Renvela	90 in 1 CARTON	POWDER, FOR SUSPENSION	90	47
58468-0131-5	Renvela	15 in 1 CARTON	POWDER, FOR SUSPENSION	15	47

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
58468-0131-1	EA - Each	58468-0131	a78ee8a3-e8b3-4dbc-99ca-4f60e2082804	1	2012-07-24
58468-0131-2	EA - Each	58468-0131	d108aa22-b40a-48a2-81cb-3d36e90c92c5	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SEVELAMER CARBONATE	ACTIVE INGREDIENT	9YCX42I8IU	RENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION [GENZYME CORPORATION]	13
SEVELAMER	ACTIVE MOIETY	941N5DUU5C	RENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION [GENZYME CORPORATION]	13
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	RENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION [GENZYME CORPORATION]	13
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	RENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION [GENZYME CORPORATION]	13
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	RENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION [GENZYME CORPORATION]	13
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	RENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION [GENZYME CORPORATION]	13
PROPYLENE GLYCOL ALGINATE	INACTIVE INGREDIENT	26CD3J2R0C	RENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION [GENZYME CORPORATION]	13
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	RENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION [GENZYME CORPORATION]	13
SUCRALOSE	INACTIVE INGREDIENT	96K6UQ3ZD4	RENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION [GENZYME CORPORATION]	13
ZINC STEARATE	INACTIVE INGREDIENT	H92E6QA4FV	RENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION [GENZYME CORPORATION]	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58468-0131	RENVELA (SEVELAMER CARBONATE) POWDER, FOR SUSPENSION RENVELA (SEVELAMER CARBONATE) TABLET, FILM COATED [GENZYME CORPORATION]	43	Current NDC, Legacy NDC, 5 package rows	20230926_e6328460-a57b-450b-a48c-6dcd4b476360.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
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): 022318 application number: NDA022318
Renvela	SEVELAMER CARBONATE	Genzyme Corporation	e6328460-a57b-450b-a48c-6dcd4b476360	2025-11-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022318 application number: NDA022318 ndc (product): 58468-0131

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
861377	Renvela 0.8 GM Powder for Oral Suspension	PSN	e6328460-a57b-450b-a48c-6dcd4b476360	47
861373	Renvela 2.4 GM Powder for Oral Suspension	PSN	e6328460-a57b-450b-a48c-6dcd4b476360	47
749210	Renvela 800 MG Oral Tablet	PSN	e6328460-a57b-450b-a48c-6dcd4b476360	47
861375	sevelamer carbonate 0.8 GM Powder for Oral Suspension	PSN	e6328460-a57b-450b-a48c-6dcd4b476360	47
861370	sevelamer carbonate 2.4 GM Powder for Oral Suspension	PSN	e6328460-a57b-450b-a48c-6dcd4b476360	47
749206	sevelamer carbonate 800 MG Oral Tablet	PSN	e6328460-a57b-450b-a48c-6dcd4b476360	47
861373	sevelamer carbonate 2400 MG Powder for Oral Suspension [Renvela]	SBD	e6328460-a57b-450b-a48c-6dcd4b476360	47
749210	sevelamer carbonate 800 MG Oral Tablet [Renvela]	SBD	e6328460-a57b-450b-a48c-6dcd4b476360	47
861377	sevelamer carbonate 800 MG Powder for Oral Suspension [Renvela]	SBD	e6328460-a57b-450b-a48c-6dcd4b476360	47
861370	sevelamer carbonate 2400 MG Powder for Oral Suspension	SCD	e6328460-a57b-450b-a48c-6dcd4b476360	47
749206	sevelamer carbonate 800 MG Oral Tablet	SCD	e6328460-a57b-450b-a48c-6dcd4b476360	47
861375	sevelamer carbonate 800 MG Powder for Oral Suspension	SCD	e6328460-a57b-450b-a48c-6dcd4b476360	47
861377	Renvela 0.8 GM Powder for Oral Suspension	SY	e6328460-a57b-450b-a48c-6dcd4b476360	47
861373	Renvela 2.4 GM Powder for Oral Suspension	SY	e6328460-a57b-450b-a48c-6dcd4b476360	47
861373	Renvela 2400 MG Powder for Oral Suspension	SY	e6328460-a57b-450b-a48c-6dcd4b476360	47
749210	Renvela 800 MG Oral Tablet	SY	e6328460-a57b-450b-a48c-6dcd4b476360	47
861377	Renvela 800 MG Powder for Oral Suspension	SY	e6328460-a57b-450b-a48c-6dcd4b476360	47
861375	sevelamer carbonate 0.8 GM Powder for Oral Suspension	SY	e6328460-a57b-450b-a48c-6dcd4b476360	47
861370	sevelamer carbonate 2.4 GM Powder for Oral Suspension	SY	e6328460-a57b-450b-a48c-6dcd4b476360	47

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58468-0131-1	58468013101	1 in 1 PACKET						Historical
58468-0131-2	58468013102	90 PACKET in 1 CARTON (58468-0131-2) / 1 POWDER, FOR SUSPENSION in 1 PACKET (58468-0131-1)	90 packet	2009-08-12	0000-00-00	No	No	Current
58468-0131-3	58468013103	1 in 1 PACKET						Historical
58468-0131-4	58468013104	90 in 1 CARTON						Historical
58468-0131-5	58468013105	15 in 1 CARTON						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Renvela	Genzyme Corporation \| Reed-Lane, Inc. \| HVL Pharma UK Limited \| Eurofins Biopharma Product Testing Ireland Limited \| Rovi Pharma Industrial Services SA \| Sanofi Winthrop Industrie \| Genzyme Ireland Limited	2025-11-25	HUMAN PRESCRIPTION DRUG LABEL	47