Sevelamer Carbonate

Product NDC
73190-014
11-digit product format
731900014
Labeler code
73190
Product ID
73190-014_41890253-11fc-7318-e063-6394a90a9a69
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sevelamer Carbonate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA200959
Marketing category
ANDA
Marketing start
2025-10-19
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

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
A200959-001SEVELAMER CARBONATESEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A200959-001AB

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 06:07:402026-07A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-203f01610625f2…
2019-09-15 20:21 UTC2019-09A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A200959-001SEVELAMER CARBONATE800MGTABLET / ORALAB2018-03-20e64feba35796…

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 06:07:402026-07A200959-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A200959-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200959-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200959-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200959-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200959-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200959-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200959-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200959-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200959-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200959-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200959-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200959-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200959-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200959-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A200959-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A200959-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A200959-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A200959-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A200959-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A200959-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A200959-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A200959-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A200959-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A200959-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A200959-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A200959-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A200959-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A200959-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A200959-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A200959-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A200959-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A200959-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A200959-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A200959-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A200959-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A200959-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A200959-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A200959-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A200959-001AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Sevelamer Carbonate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SEVELAMER CARBONATE800 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9YCX42I8IUInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
749206Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
41890246-efa5-524a-e063-6294a90a5ad9Available on FDA.report

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
73190-014-27Sevelamer Carbonate270 in 1 BOTTLETABLET, FILM COATED2701

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73190-014-27EA - Each73190-0149b2a1365-03c3-4f86-b656-57f32d925b4d12025-12-16

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sevelamer CarbonateSEVELAMER CARBONATEAvKARE41890246-efa5-524a-e063-6294a90a5ad92025-10-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200959
application number: ANDA200959
ndc (product): 73190-014
Sevelamer CarbonateSEVELAMER CARBONATEWestminster Pharmaceuticals, LLC45a955e9-94ac-48db-838c-74934eae245b2025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200959
application number: ANDA200959
Sevelamer CarbonateSEVELAMER CARBONATETWi Pharmaceuticals, Inc.05b076d9-6516-4538-8e05-9709a677ed2f2024-08-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200959
application number: ANDA200959
Sevelamer CarbonateSEVELAMER CARBONATEProficient Rx LPee9da697-2d55-48e5-8e03-c64c8aaf1fb82024-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200959
application number: ANDA200959

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749206sevelamer carbonate 800 MG Oral TabletPSN41890246-efa5-524a-e063-6294a90a5ad91
749206sevelamer carbonate 800 MG Oral TabletSCD41890246-efa5-524a-e063-6294a90a5ad91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
73190-014-2773190001427270 TABLET, FILM COATED in 1 BOTTLE (73190-014-27) 2025-10-19NoNoCurrent