Sevelamer Carbonate

Product NDC
72162-2499
11-digit product format
721622499
Labeler code
72162
Product ID
72162-2499_a111b64e-c229-4213-bae7-48bd2a42f2c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sevelamer Carbonate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA206100
Marketing category
ANDA
Marketing start
2023-04-19
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
A206100-001SEVELAMER CARBONATESEVELAMER CARBONATE800MGTABLET / ORALAB2023-04-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206100-001AB

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 06:07:402026-07A206100-001SEVELAMER CARBONATE800MGTABLET / ORALAB2023-04-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206100-001SEVELAMER CARBONATE800MGTABLET / ORALAB2023-04-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206100-001SEVELAMER CARBONATE800MGTABLET / ORALAB2023-04-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A206100-001SEVELAMER CARBONATE800MGTABLET / ORALAB2023-04-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206100-001SEVELAMER CARBONATE800MGTABLET / ORALAB2023-04-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206100-001SEVELAMER CARBONATE800MGTABLET / ORALAB2023-04-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206100-001SEVELAMER CARBONATE800MGTABLET / ORALAB2023-04-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206100-001SEVELAMER CARBONATE800MGTABLET / ORALAB2023-04-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206100-001SEVELAMER CARBONATE800MGTABLET / ORALAB2023-04-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206100-001SEVELAMER CARBONATE800MGTABLET / ORALAB2023-04-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206100-001SEVELAMER CARBONATE800MGTABLET / ORALAB2023-04-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206100-001SEVELAMER CARBONATE800MGTABLET / ORALAB2023-04-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206100-001SEVELAMER CARBONATE800MGTABLET / ORALAB2023-04-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206100-001SEVELAMER CARBONATE800MGTABLET / ORALAB2023-04-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206100-001SEVELAMER CARBONATE800MGTABLET / ORALAB2023-04-198072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206100-001SEVELAMER CARBONATE800MGTABLET / ORALAB2023-04-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206100-001SEVELAMER CARBONATE800MGTABLET / ORALAB2023-04-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206100-001SEVELAMER CARBONATE800MGTABLET / ORALAB2023-04-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206100-001SEVELAMER CARBONATE800MGTABLET / ORALAB2023-04-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206100-001SEVELAMER CARBONATE800MGTABLET / ORALAB2023-04-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206100-001SEVELAMER CARBONATE800MGTABLET / ORALAB2023-04-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206100-001SEVELAMER CARBONATE800MGTABLET / ORALAB2023-04-193f0d92c62455…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206100-001SEVELAMER CARBONATE800MGTABLET / ORALAB2023-04-19a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A206100-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206100-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206100-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206100-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206100-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206100-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206100-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206100-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206100-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206100-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206100-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206100-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206100-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206100-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206100-001AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206100-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206100-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206100-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206100-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206100-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206100-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206100-001AB13f0d92c62455…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206100-001AB1a50c72e98297…

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
462a11b9-78a3-4d8b-ae5d-3d6528e4d743Available 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
72162-2499-1Sevelamer Carbonate100 in 1 BOTTLETABLET, FILM COATED100101
72162-2499-2Sevelamer Carbonate270 in 1 BOTTLETABLET, FILM COATED270101
72162-2499-4Sevelamer Carbonate50 in 1 BOTTLETABLET, FILM COATED50101
72162-2499-9Sevelamer Carbonate90 in 1 BOTTLETABLET, FILM COATED90101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2499-1EA - Each72162-24995238e446-be51-4bec-901b-7aef731dfce812025-06-13
72162-2499-2EA - Each72162-24992a185afd-145b-4001-b4cf-13cd2abac2c812025-06-13
72162-2499-4EA - Each72162-24999c709934-f086-4e7c-9843-58512f06627e12025-06-13
72162-2499-9EA - Each72162-249902933484-a612-4366-bfce-d58db9f514a712025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2499SEVELAMER CARBONATE TABLET, FILM COATED [BRYANT RANCH PREPACK]100Current NDC, 4 package rows20250519_462a11b9-78a3-4d8b-ae5d-3d6528e4d743.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sevelamer CarbonateSEVELAMER CARBONATEMacleods Pharmaceuticals Limited4c927d50-34a6-499b-b1c2-924d4eb739872026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206100
application number: ANDA206100
Sevelamer CarbonateSEVELAMER CARBONATEBryant Ranch Prepack462a11b9-78a3-4d8b-ae5d-3d6528e4d7432025-11-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206100
application number: ANDA206100
ndc (product): 72162-2499

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749206sevelamer carbonate 800 MG Oral TabletPSN462a11b9-78a3-4d8b-ae5d-3d6528e4d743101
749206sevelamer carbonate 800 MG Oral TabletSCD462a11b9-78a3-4d8b-ae5d-3d6528e4d743101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2499-172162249901100 TABLET, FILM COATED in 1 BOTTLE (72162-2499-1) 2025-05-15NoNoCurrent
72162-2499-272162249902270 TABLET, FILM COATED in 1 BOTTLE (72162-2499-2) 2025-05-15NoNoCurrent
72162-2499-47216224990450 TABLET, FILM COATED in 1 BOTTLE (72162-2499-4) 2025-05-15NoNoCurrent
72162-2499-97216224990990 TABLET, FILM COATED in 1 BOTTLE (72162-2499-9) 2025-05-15NoNoCurrent