Sevelamer Carbonate

Product NDC
17856-0058
11-digit product format
178560058
Labeler code
17856
Product ID
17856-0058_0a9c5e53-1d81-4eb9-9c8b-1d999ce54769
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sevelamer Carbonate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Atlantic Biologicals Corps
Application
ANDA207288
Marketing category
ANDA
Marketing start
2017-11-28
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
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 productproduct17856-0058IInactivated by FDA2026-08-17
excluded packagepackage17856-005817856-0058-3IInactivated by FDA2026-08-17

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 · 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 packagepackage17856-0058-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage17856-0058-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage17856-0058-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage17856-0058-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage17856-0058-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage17856-0058-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage17856-0058-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage17856-0058-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage17856-0058-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage17856-0058-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage17856-0058-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage17856-0058-3557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage17856-0058-38af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage17856-0058-3834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage17856-0058-31332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage17856-0058-3fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage17856-0058-386f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage17856-0058-3bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage17856-0058-38dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage17856-0058-3e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage17856-0058-39bebd1f3094a…5416666fcb17…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A207288-001SEVELAMER CARBONATESEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A207288-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-283f01610625f2…
2019-09-15 20:21 UTC2019-09A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207288-001SEVELAMER CARBONATE800MGTABLET / ORALAB2017-11-28e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A207288-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207288-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207288-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207288-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207288-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207288-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207288-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207288-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207288-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207288-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207288-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207288-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207288-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207288-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207288-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207288-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207288-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207288-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207288-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207288-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207288-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207288-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A207288-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207288-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207288-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207288-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A207288-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207288-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207288-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207288-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207288-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207288-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207288-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207288-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207288-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207288-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207288-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207288-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207288-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207288-001AB1e64feba35796…

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
17856-0058-3Sevelamer Carbonate1 in 1 POUCHTABLET, FILM COATED12
17856-0058-3Sevelamer Carbonate100 in 1 CASETABLET, FILM COATED1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0058SEVELAMER CARBONATE TABLET, FILM COATED [ATLANTIC BIOLOGICALS CORPS]2Legacy NDC, 2 package rows20180305_90caaf0e-de31-48bc-8286-c02ef380e8b2.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sevelamer CarbonateSEVELAMER CARBONATEAvPAK7f701cb4-3089-375f-e053-2991aa0a51b92026-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207288
application number: ANDA207288
Sevelamer CarbonateSEVELAMER CARBONATEPrecision Dose, Inc.09b5e422-18c9-49dc-be3d-5d24648184af2025-08-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207288
application number: ANDA207288
Sevelamer CarbonateSEVELAMER CARBONATEAmneal Pharmaceuticals LLC94d8cfb1-ff2a-4956-8954-17635ac505d92023-11-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207288
application number: ANDA207288

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749206sevelamer carbonate 800 MG Oral TabletPSN90caaf0e-de31-48bc-8286-c02ef380e8b22
749206sevelamer carbonate 800 MG Oral TabletSCD90caaf0e-de31-48bc-8286-c02ef380e8b22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
17856-0058-3178560058031 in 1 POUCHHistorical