RENAGEL

Product NDC
68151-4295
11-digit product format
681514295
Labeler code
68151
Product ID
68151-4295_659e4de8-1232-4c9e-ab20-7e0d3af01700
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Renagel
Dosage form
TABLET
Route
ORAL
Labeler
Carilion Materials Management
Application
NDA021179
Marketing category
NDA
Marketing start
2008-06-06
Marketing end
0000-00-00
Substance
SEVELAMER HYDROCHLORIDE
Active strength
400 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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68151-4295IInactivated by FDA2026-08-03
excluded packagepackage68151-429568151-4295-1IInactivated by FDA2026-08-03

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 dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68151-4295-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68151-4295-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68151-4295-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68151-4295-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68151-4295-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68151-4295-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68151-4295-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68151-4295-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68151-4295-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68151-4295-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68151-4295-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68151-4295-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68151-4295-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68151-4295-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68151-4295-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68151-4295-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68151-4295-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68151-4295-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68151-4295-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68151-4295-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68151-4295-19bebd1f3094a…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021179-001RENAGELSEVELAMER HYDROCHLORIDE400MGTABLET / ORALABRLD2000-07-12
N021179-002RENAGELSEVELAMER HYDROCHLORIDE800MGTABLET / ORALABRLD, RS2000-07-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N021179-001AB
N021179-002AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021179-001RENAGEL400MGTABLET / ORALABRLD2000-07-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021179-002RENAGEL800MGTABLET / ORALABRLD, RS2000-07-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021179-001RENAGEL400MGTABLET / ORALABRLD2000-07-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021179-002RENAGEL800MGTABLET / ORALABRLD, RS2000-07-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08N021179-001RENAGEL400MGTABLET / ORALABRLD2000-07-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021179-002RENAGEL800MGTABLET / ORALABRLD, RS2000-07-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021179-001RENAGEL400MGTABLET / ORALABRLD2000-07-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021179-002RENAGEL800MGTABLET / ORALABRLD, RS2000-07-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021179-001RENAGEL400MGTABLET / ORALABRLD2000-07-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021179-002RENAGEL800MGTABLET / ORALABRLD, RS2000-07-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021179-001RENAGEL400MGTABLET / ORALABRLD2000-07-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021179-002RENAGEL800MGTABLET / ORALABRLD, RS2000-07-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021179-001RENAGEL400MGTABLET / ORALABRLD2000-07-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021179-002RENAGEL800MGTABLET / ORALABRLD, RS2000-07-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021179-001RENAGEL400MGTABLET / ORALABRLD2000-07-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021179-002RENAGEL800MGTABLET / ORALABRLD, RS2000-07-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021179-001RENAGEL400MGTABLET / ORALABRLD2000-07-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021179-002RENAGEL800MGTABLET / ORALABRLD, RS2000-07-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021179-001RENAGEL400MGTABLET / ORALABRLD2000-07-12d06236e962d9…
2024-10-29 15:01 UTC2024-10N021179-002RENAGEL800MGTABLET / ORALABRLD, RS2000-07-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021179-001RENAGEL400MGTABLET / ORALABRLD2000-07-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021179-002RENAGEL800MGTABLET / ORALABRLD, RS2000-07-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021179-001RENAGEL400MGTABLET / ORALABRLD2000-07-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021179-002RENAGEL800MGTABLET / ORALABRLD, RS2000-07-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021179-001RENAGEL400MGTABLET / ORALABRLD2000-07-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021179-002RENAGEL800MGTABLET / ORALABRLD, RS2000-07-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021179-001RENAGEL400MGTABLET / ORALABRLD2000-07-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021179-002RENAGEL800MGTABLET / ORALABRLD, RS2000-07-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021179-001RENAGEL400MGTABLET / ORALABRLD2000-07-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021179-002RENAGEL800MGTABLET / ORALABRLD, RS2000-07-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021179-001RENAGEL400MGTABLET / ORALABRLD2000-07-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021179-002RENAGEL800MGTABLET / ORALABRLD, RS2000-07-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021179-001RENAGEL400MGTABLET / ORALABRLD2000-07-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021179-002RENAGEL800MGTABLET / ORALABRLD, RS2000-07-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021179-001RENAGEL400MGTABLET / ORALABRLD2000-07-1274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021179-002RENAGEL800MGTABLET / ORALABRLD, RS2000-07-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021179-001RENAGEL400MGTABLET / ORALABRLD2000-07-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021179-002RENAGEL800MGTABLET / ORALABRLD, RS2000-07-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021179-001RENAGEL400MGTABLET / ORALABRLD2000-07-12782e0a99824c…
2021-12-28 21:50 UTC2021-12N021179-002RENAGEL800MGTABLET / ORALABRLD, RS2000-07-12782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021179-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021179-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021179-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021179-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021179-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021179-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021179-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021179-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021179-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021179-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021179-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021179-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021179-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021179-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021179-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021179-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021179-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021179-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021179-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021179-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021179-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021179-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021179-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021179-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021179-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021179-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021179-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021179-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021179-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021179-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021179-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021179-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021179-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021179-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021179-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021179-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021179-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N021179-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021179-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12N021179-002AB1782e0a99824c…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021179-00167337802020-10-18Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021179-00267337802020-10-18Drug product74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021179-00167337802020-10-18Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N021179-00267337802020-10-18Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021179-00167337802020-10-18Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N021179-00267337802020-10-18Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021179-00167337802020-10-18Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N021179-00267337802020-10-18Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N021179-00167337802020-10-18Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N021179-00267337802020-10-18Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N021179-00167337802020-10-18Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N021179-00267337802020-10-18Drug productea99ee380514…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5085f16b-f856-182d-a646-425b62d3f565Product name620251118
86e7ef73-ca63-701e-e952-6c80aa5122b8Product name920210309

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-4295-1RENAGEL1 in 1 BLISTER PACKTABLET13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-4295RENAGEL TABLET [CARILION MATERIALS MANAGEMENT]3Legacy NDC, 1 package rows20180215_9281598e-60de-4f4f-8e01-0a7dfef92dd3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857218RenaGel 400 MG Oral TabletPSN9281598e-60de-4f4f-8e01-0a7dfef92dd33
857216sevelamer HCl 400 MG Oral TabletPSN9281598e-60de-4f4f-8e01-0a7dfef92dd33
857218sevelamer hydrochloride 400 MG Oral Tablet [RenaGel]SBD9281598e-60de-4f4f-8e01-0a7dfef92dd33
857216sevelamer hydrochloride 400 MG Oral TabletSCD9281598e-60de-4f4f-8e01-0a7dfef92dd33
857218RenaGel 400 MG Oral TabletSY9281598e-60de-4f4f-8e01-0a7dfef92dd33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-4295-1681514295011 in 1 BLISTER PACKHistorical