Home NDC 55154-2647 sevelamer hydrochloride
Product NDC 55154-2647
11-digit product format 551542647
Labeler code 55154
Product ID 55154-2647_cd703ad5-7d31-462e-971e-44bd794498ba
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sevelamer hydrochloride
Dosage form TABLET, FILM COATED
Route PARENTERAL
Labeler Cardinal Health 107, LLC
Application ANDA204724
Marketing category ANDA
Marketing start 2025-02-25
Substance SEVELAMER HYDROCHLORIDE
Active strength 800 mg/1
Pharmacologic classes Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204724-001 SEVELAMER HYDROCHLORIDE SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2019-02-08 A204724-002 SEVELAMER HYDROCHLORIDE SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2019-02-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 82 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 2026-02-19 14:30 UTC 2026-02 A204724-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2019-02-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204724-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2019-02-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204724-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2019-02-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204724-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2019-02-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204724-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2019-02-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204724-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2019-02-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204724-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2019-02-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204724-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2019-02-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204724-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2019-02-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204724-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2019-02-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204724-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2019-02-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204724-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2019-02-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204724-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2019-02-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204724-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2019-02-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204724-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2019-02-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204724-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2019-02-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204724-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2019-02-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204724-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2019-02-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204724-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2019-02-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204724-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2019-02-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204724-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2019-02-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204724-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2019-02-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204724-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2019-02-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204724-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2019-02-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204724-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2019-02-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204724-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2019-02-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204724-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2019-02-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204724-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2019-02-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204724-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2019-02-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204724-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2019-02-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204724-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2019-02-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A204724-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2019-02-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204724-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2019-02-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A204724-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2019-02-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204724-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2019-02-08 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A204724-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2019-02-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204724-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2019-02-08 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A204724-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2019-02-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204724-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2019-02-08 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A204724-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2019-02-08 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base sevelamer hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SEVELAMER HYDROCHLORIDE 800 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination GLS2PGI8QG Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 857224 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 55154-2647-0 sevelamer hydrochloride 1 in 1 BLISTER PACK TABLET, FILM COATED 1 2 55154-2647-0 sevelamer hydrochloride 10 in 1 BAG TABLET, FILM COATED 10 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55154-2647 SEVELAMER HYDROCHLORIDE TABLET, FILM COATED [CARDINAL HEALTH 107, LLC] 1 Current NDC, 2 package rows 20250228_c13532a7-4c56-4084-839d-3dcfd4dc30f8.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 · 5 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 55154-2647-0 55154264700 10 BLISTER PACK in 1 BAG (55154-2647-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK 10 blister pack 2025-02-25 No No Current