Home NDC 0955-1054 Sevelamer Carbonate
Product NDC 0955-1054
11-digit product format 009551054
Labeler code 0955
Product ID 0955-1054_42bdb389-5550-487c-aed2-c4e3afd239c8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sevelamer Carbonate
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Sanofi-Aventis U.S. LLC
Application NDA022318
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2018-01-01
Substance SEVELAMER CARBONATE
Active strength 2.4 g/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 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 N022318-001 RENVELA SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL RLD 2009-08-12 N022318-002 RENVELA SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL RLD 2009-02-18
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022318-001 9095509 2030-12-06 Drug product 2016-01-13 N022318-002 9095509 2030-12-06 Drug product 2016-01-13
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 N022318-001 RENVELA 800MG/PACKET FOR SUSPENSION / ORAL AB RLD 2009-08-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022318-002 RENVELA 2.4GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-02-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022318-001 RENVELA 800MG/PACKET FOR SUSPENSION / ORAL AB RLD 2009-08-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022318-002 RENVELA 2.4GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-02-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022318-001 RENVELA 800MG/PACKET FOR SUSPENSION / ORAL AB RLD 2009-08-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022318-002 RENVELA 2.4GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-02-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022318-001 RENVELA 800MG/PACKET FOR SUSPENSION / ORAL AB RLD 2009-08-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022318-002 RENVELA 2.4GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-02-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022318-001 RENVELA 800MG/PACKET FOR SUSPENSION / ORAL AB RLD 2009-08-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022318-002 RENVELA 2.4GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-02-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022318-001 RENVELA 800MG/PACKET FOR SUSPENSION / ORAL AB RLD 2009-08-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022318-002 RENVELA 2.4GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-02-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022318-001 RENVELA 800MG/PACKET FOR SUSPENSION / ORAL AB RLD 2009-08-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022318-002 RENVELA 2.4GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-02-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022318-001 RENVELA 800MG/PACKET FOR SUSPENSION / ORAL AB RLD 2009-08-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022318-002 RENVELA 2.4GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-02-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022318-001 RENVELA 800MG/PACKET FOR SUSPENSION / ORAL AB RLD 2009-08-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022318-002 RENVELA 2.4GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-02-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022318-001 RENVELA 800MG/PACKET FOR SUSPENSION / ORAL AB RLD 2009-08-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022318-002 RENVELA 2.4GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-02-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022318-001 RENVELA 800MG/PACKET FOR SUSPENSION / ORAL AB RLD 2009-08-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022318-002 RENVELA 2.4GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-02-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022318-001 RENVELA 800MG/PACKET FOR SUSPENSION / ORAL AB RLD 2009-08-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022318-002 RENVELA 2.4GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-02-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022318-001 RENVELA 800MG/PACKET FOR SUSPENSION / ORAL AB RLD 2009-08-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022318-002 RENVELA 2.4GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-02-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022318-001 RENVELA 800MG/PACKET FOR SUSPENSION / ORAL AB RLD 2009-08-12 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022318-002 RENVELA 2.4GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-02-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022318-001 RENVELA 800MG/PACKET FOR SUSPENSION / ORAL AB RLD 2009-08-12 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022318-002 RENVELA 2.4GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-02-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022318-001 RENVELA 800MG/PACKET FOR SUSPENSION / ORAL AB RLD 2009-08-12 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022318-002 RENVELA 2.4GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-02-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022318-001 RENVELA 800MG/PACKET FOR SUSPENSION / ORAL AB RLD 2009-08-12 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022318-002 RENVELA 2.4GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-02-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022318-001 RENVELA 800MG/PACKET FOR SUSPENSION / ORAL AB RLD 2009-08-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022318-002 RENVELA 2.4GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-02-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022318-001 RENVELA 800MG/PACKET FOR SUSPENSION / ORAL AB RLD 2009-08-12 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022318-002 RENVELA 2.4GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-02-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022318-001 RENVELA 800MG/PACKET FOR SUSPENSION / ORAL AB RLD 2009-08-12 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022318-002 RENVELA 2.4GM/PACKET FOR SUSPENSION / ORAL AB RLD, RS 2009-02-18 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 80 observed states.
Observed Orange Book patent history# Patent history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022318-001 9095509 2030-12-06 Drug product 2016-01-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022318-002 9095509 2030-12-06 Drug product 2016-01-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022318-001 9095509 2030-12-06 Drug product 2016-01-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022318-002 9095509 2030-12-06 Drug product 2016-01-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022318-001 9095509 2030-12-06 Drug product 2016-01-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022318-002 9095509 2030-12-06 Drug product 2016-01-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022318-001 9095509 2030-12-06 Drug product 2016-01-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022318-002 9095509 2030-12-06 Drug product 2016-01-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022318-001 9095509 2030-12-06 Drug product 2016-01-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022318-002 9095509 2030-12-06 Drug product 2016-01-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022318-001 9095509 2030-12-06 Drug product 2016-01-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022318-002 9095509 2030-12-06 Drug product 2016-01-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022318-001 9095509 2030-12-06 Drug product 2016-01-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022318-002 9095509 2030-12-06 Drug product 2016-01-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022318-001 9095509 2030-12-06 Drug product 2016-01-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022318-002 9095509 2030-12-06 Drug product 2016-01-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022318-001 9095509 2030-12-06 Drug product 2016-01-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022318-002 9095509 2030-12-06 Drug product 2016-01-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022318-001 9095509 2030-12-06 Drug product 2016-01-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022318-002 9095509 2030-12-06 Drug product 2016-01-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022318-001 9095509 2030-12-06 Drug product 2016-01-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022318-002 9095509 2030-12-06 Drug product 2016-01-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022318-001 9095509 2030-12-06 Drug product 2016-01-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022318-002 9095509 2030-12-06 Drug product 2016-01-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022318-001 9095509 2030-12-06 Drug product 2016-01-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022318-002 9095509 2030-12-06 Drug product 2016-01-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022318-001 9095509 2030-12-06 Drug product 2016-01-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022318-002 9095509 2030-12-06 Drug product 2016-01-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022318-001 9095509 2030-12-06 Drug product 2016-01-13 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022318-002 9095509 2030-12-06 Drug product 2016-01-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022318-001 9095509 2030-12-06 Drug product 2016-01-13 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022318-002 9095509 2030-12-06 Drug product 2016-01-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022318-001 9095509 2030-12-06 Drug product 2016-01-13 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022318-002 9095509 2030-12-06 Drug product 2016-01-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022318-001 9095509 2030-12-06 Drug product 2016-01-13 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022318-002 9095509 2030-12-06 Drug product 2016-01-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022318-001 9095509 2030-12-06 Drug product 2016-01-13 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N022318-002 9095509 2030-12-06 Drug product 2016-01-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022318-001 9095509 2030-12-06 Drug product 2016-01-13 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N022318-002 9095509 2030-12-06 Drug product 2016-01-13 782e0a99824c…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Sevelamer Carbonate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SEVELAMER CARBONATE 2.4 g/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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 749206 Internal RxNorm lookup 861370 Internal RxNorm lookup 861375 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 0955-1054-01 Sevelamer Carbonate 1 in 1 PACKET POWDER, FOR SUSPENSION 1 20 0955-1054-90 Sevelamer Carbonate 90 in 1 BOX POWDER, FOR SUSPENSION 90 20
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0955-1054 SEVELAMER CARBONATE TABLET, FILM COATED SEVELAMER CARBONATE POWDER, FOR SUSPENSION [SANOFI-AVENTIS U.S. LLC] 19 Current NDC, Legacy NDC, 2 package rows 20250213_3abc32fe-1bfc-4759-8f7c-36095e221b06.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.
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 0955-1054-01 00955105401 1 in 1 PACKET Historical 0955-1054-90 00955105490 90 PACKET in 1 BOX (0955-1054-90) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0955-1054-01) 90 packet 2018-01-01 0000-00-00 No No Current