Home NDC 55154-3358 Sevelamer Carbonate
Product NDC 55154-3358
11-digit product format 551543358
Labeler code 55154
Product ID 55154-3358_d32d8ace-7628-4b19-805b-83541f82ce35
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sevelamer Carbonate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Cardinal Health 107, LLC
Application ANDA206094
Marketing category ANDA
Marketing start 2017-09-29
Marketing end 2026-12-31
Substance SEVELAMER CARBONATE
Active strength 800 mg/1
Pharmacologic classes Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206094-001 SEVELAMER CARBONATE SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206094-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206094-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2017-09-29 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Sevelamer Carbonate Active Ingredients# Ingredient, Strength table Ingredient Strength SEVELAMER CARBONATE 800 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9YCX42I8IU Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 749206 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55154-3358-0 Sevelamer Carbonate 10 in 1 BAG TABLET, FILM COATED 10 6 55154-3358-0 Sevelamer Carbonate 1 in 1 BLISTER PACK TABLET, FILM COATED 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55154-3358 SEVELAMER CARBONATE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20240910_65184825-adce-480e-a4c3-b21e37656cf4.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55154-3358-0 55154335800 10 BLISTER PACK in 1 BAG (55154-3358-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK 10 blister pack 2017-09-29 2026-12-31 No No Current