FDA.reportPublic FDA data

SEVELAMER CARBONATE

Product NDC
42571-378
Requested package NDC
42571-378-43
11-digit product format
425710378
Labeler code
42571
Product ID
42571-378_d807f196-f1f8-0a8f-e053-2a95a90aab8d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SEVELAMER CARBONATE
Dosage form
TABLET
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA215537
Marketing category
ANDA
Marketing start
2022-05-01
Substance
SEVELAMER CARBONATE
Active strength
800 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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage42571-37842571-378-43DDiscontinued by firm2026-08-17

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
A215537-001SEVELAMER CARBONATESEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215537-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A215537-001SEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215537-001SEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215537-001SEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A215537-001SEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215537-001SEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215537-001SEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215537-001SEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215537-001SEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215537-001SEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215537-001SEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215537-001SEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215537-001SEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215537-001SEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215537-001SEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215537-001SEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215537-001SEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A215537-001SEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A215537-001SEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-074b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A215537-001SEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-07bb7c543d1eb4…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215537-001SEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215537-001SEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215537-001SEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215537-001SEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215537-001SEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215537-001SEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A215537-001SEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A215537-001SEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A215537-001SEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A215537-001SEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A215537-001SEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A215537-001SEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A215537-001SEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-07cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215537-001SEVELAMER CARBONATE800MGTABLET / ORALAB2022-02-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A215537-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215537-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215537-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215537-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215537-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A215537-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A215537-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A215537-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A215537-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A215537-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A215537-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A215537-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A215537-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A215537-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A215537-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A215537-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A215537-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A215537-001AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A215537-001AB1bb7c543d1eb4…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A215537-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A215537-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A215537-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A215537-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A215537-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A215537-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A215537-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A215537-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A215537-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A215537-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A215537-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A215537-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A215537-001AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215537-001AB1a50c72e98297…

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42571-378-30SEVELAMER CARBONATE30 in 1 BOTTLETABLET301
42571-378-43SEVELAMER CARBONATE270 in 1 BOTTLETABLET2701

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-378SEVELAMER CARBONATE (SEVELAMER CARBONATE) TABLET [MICRO LABS LIMITED]1Current NDC, Legacy NDC, 2 package rows20220501_9977f652-b3e7-43bc-bf3f-1f54698c5f7a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749206sevelamer carbonate 800 MG Oral TabletPSN9977f652-b3e7-43bc-bf3f-1f54698c5f7a1
749206sevelamer carbonate 800 MG Oral TabletSCD9977f652-b3e7-43bc-bf3f-1f54698c5f7a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-378-4342571037843270 TABLET in 1 BOTTLE (42571-378-43) 270 tablet2022-05-010000-00-00NoNoCurrent