Renagel

Product NDC: 53808-0777
11-digit product format: 538080777
Labeler code: 53808
Product ID: 53808-0777_5ec67fac-794f-4ca5-a5ef-6a0cf51565e0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Renagel
Dosage form: TABLET
Route: ORAL
Labeler: DOH CENTRAL PHARMACY
Application: NDA021179
Marketing category: NDA
Marketing start: 2009-07-01
Marketing end: 0000-00-00
Substance: SEVELAMER HYDROCHLORIDE
Active strength: 800 mg/1
Pharmacologic classes: Phosphate Binder [EPC],Phosphate Chelating Activity [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53808-0777		I	Inactivated by FDA		2026-08-03
excluded package	package	53808-0777	53808-0777-1	I	Inactivated by FDA		2026-08-03

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53808-0777-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53808-0777-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53808-0777-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53808-0777-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53808-0777-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53808-0777-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53808-0777-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53808-0777-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53808-0777-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53808-0777-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53808-0777-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	53808-0777-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	53808-0777-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	53808-0777-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	53808-0777-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	53808-0777-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	53808-0777-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	53808-0777-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	53808-0777-1	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	53808-0777-1	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53808-0777-1	`9bebd1f3094a…`	`5416666fcb17…`

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
N021179-001	RENAGEL	SEVELAMER HYDROCHLORIDE	400MG	TABLET / ORAL	AB	RLD	2000-07-12
N021179-002	RENAGEL	SEVELAMER HYDROCHLORIDE	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N021179-001	AB
N021179-002	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 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	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021179-001	RENAGEL	400MG	TABLET / ORAL	AB	RLD	2000-07-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021179-002	RENAGEL	800MG	TABLET / ORAL	AB	RLD, RS	2000-07-12	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	N021179-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021179-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021179-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021179-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021179-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021179-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021179-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021179-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021179-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021179-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021179-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021179-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021179-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021179-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021179-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021179-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021179-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021179-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021179-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021179-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021179-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021179-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021179-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021179-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021179-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021179-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021179-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021179-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021179-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021179-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021179-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021179-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021179-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021179-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021179-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021179-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021179-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021179-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021179-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021179-002	AB	1	`782e0a99824c…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021179-001	6733780	2020-10-18	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021179-002	6733780	2020-10-18	Drug product	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021179-001	6733780	2020-10-18	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021179-002	6733780	2020-10-18	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021179-001	6733780	2020-10-18	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021179-002	6733780	2020-10-18	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021179-001	6733780	2020-10-18	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021179-002	6733780	2020-10-18	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021179-001	6733780	2020-10-18	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021179-002	6733780	2020-10-18	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021179-001	6733780	2020-10-18	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021179-002	6733780	2020-10-18	Drug product	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5085f16b-f856-182d-a646-425b62d3f565	Product name	6	20251118
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
86e7ef73-ca63-701e-e952-6c80aa5122b8	Product name	9	20210309

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53808-0777-1	2020-01-31	C162847	48780-1	9d75b9d0-d912-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Renagel safely and effectively. See full prescribing information for Renagel. Renagel (sevelamer hydrochloride) Tablet for Oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-0777-1	Renagel	30 in 1 BLISTER PACK	TABLET	30		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SEVELAMER HYDROCHLORIDE	ACTIVE INGREDIENT	GLS2PGI8QG	RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
SEVELAMER	ACTIVE MOIETY	941N5DUU5C	RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYPROMELLOSE 2910 (15 CPS)	INACTIVE INGREDIENT	36SFW2JZ0W	RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
HYPROMELLOSE 2910 (5 CPS)	INACTIVE INGREDIENT	R75537T0T4	RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53808-0777	RENAGEL TABLET [DOH CENTRAL PHARMACY]	3	Legacy NDC, 1 package rows	20170209_4a3b3dd8-9b4a-4a00-8178-eb8417195081.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
GLS2PGI8QG	SEVELAMER HYDROCHLORIDE	152751-57-0	SEVELAMER HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
857224	sevelamer HCl 800 MG Oral Tablet	PSN	4a3b3dd8-9b4a-4a00-8178-eb8417195081	3
857224	sevelamer hydrochloride 800 MG Oral Tablet	SCD	4a3b3dd8-9b4a-4a00-8178-eb8417195081	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
53808-0777-1	53808077701	30 in 1 BLISTER PACK	Historical