Home NDC 58468-0021 Renagel
Product NDC 58468-0021
11-digit product format 584680021
Labeler code 58468
Product ID 58468-0021_500d269a-adb9-499c-ad8b-d9aaa43e1ba9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sevelamer hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Genzyme Corporation
Application NDA021179
Marketing category NDA
Marketing start 2008-06-06
Marketing end 0000-00-00
Substance SEVELAMER HYDROCHLORIDE
Active strength 800 mg/1
Pharmacologic classes Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 58468-0021-1 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 58468-0021-1 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 58468-0021-1 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 58468-0021-1 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 58468-0021-1 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 58468-0021-1 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 58468-0021-1 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 58468-0021-1 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 58468-0021-1 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 58468-0021-1 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 58468-0021-1 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 58468-0021-1 557ba5c1ecfa…9c80585c8c6e…
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 N021179-001 RENAGEL SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB RLD 2000-07-12 N021179-002 RENAGEL SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB RLD, RS 2000-07-12
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 N021179-001 RENAGEL 400MG TABLET / ORAL AB RLD 2000-07-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021179-002 RENAGEL 800MG TABLET / ORAL AB RLD, RS 2000-07-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021179-001 RENAGEL 400MG TABLET / ORAL AB RLD 2000-07-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021179-002 RENAGEL 800MG TABLET / ORAL AB RLD, RS 2000-07-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021179-001 RENAGEL 400MG TABLET / ORAL AB RLD 2000-07-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021179-002 RENAGEL 800MG TABLET / ORAL AB RLD, RS 2000-07-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021179-001 RENAGEL 400MG TABLET / ORAL AB RLD 2000-07-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021179-002 RENAGEL 800MG TABLET / ORAL AB RLD, RS 2000-07-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021179-001 RENAGEL 400MG TABLET / ORAL AB RLD 2000-07-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021179-002 RENAGEL 800MG TABLET / ORAL AB RLD, RS 2000-07-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021179-001 RENAGEL 400MG TABLET / ORAL AB RLD 2000-07-12 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021179-002 RENAGEL 800MG TABLET / ORAL AB RLD, RS 2000-07-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021179-001 RENAGEL 400MG TABLET / ORAL AB RLD 2000-07-12 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021179-002 RENAGEL 800MG TABLET / ORAL AB RLD, RS 2000-07-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021179-001 RENAGEL 400MG TABLET / ORAL AB RLD 2000-07-12 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021179-002 RENAGEL 800MG TABLET / ORAL AB RLD, RS 2000-07-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021179-001 RENAGEL 400MG TABLET / ORAL AB RLD 2000-07-12 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021179-002 RENAGEL 800MG TABLET / ORAL AB RLD, RS 2000-07-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021179-001 RENAGEL 400MG TABLET / ORAL AB RLD 2000-07-12 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021179-002 RENAGEL 800MG TABLET / ORAL AB RLD, RS 2000-07-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021179-001 RENAGEL 400MG TABLET / ORAL AB RLD 2000-07-12 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021179-002 RENAGEL 800MG TABLET / ORAL AB RLD, RS 2000-07-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021179-001 RENAGEL 400MG TABLET / ORAL AB RLD 2000-07-12 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021179-002 RENAGEL 800MG TABLET / ORAL AB RLD, RS 2000-07-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021179-001 RENAGEL 400MG TABLET / ORAL AB RLD 2000-07-12 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021179-002 RENAGEL 800MG TABLET / ORAL AB RLD, RS 2000-07-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021179-001 RENAGEL 400MG TABLET / ORAL AB RLD 2000-07-12 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021179-002 RENAGEL 800MG TABLET / ORAL AB RLD, RS 2000-07-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021179-001 RENAGEL 400MG TABLET / ORAL AB RLD 2000-07-12 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021179-002 RENAGEL 800MG TABLET / ORAL AB RLD, RS 2000-07-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021179-001 RENAGEL 400MG TABLET / ORAL AB RLD 2000-07-12 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021179-002 RENAGEL 800MG TABLET / ORAL AB RLD, RS 2000-07-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021179-001 RENAGEL 400MG TABLET / ORAL AB RLD 2000-07-12 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021179-002 RENAGEL 800MG TABLET / ORAL AB RLD, RS 2000-07-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021179-001 RENAGEL 400MG TABLET / ORAL AB RLD 2000-07-12 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021179-002 RENAGEL 800MG TABLET / ORAL AB RLD, RS 2000-07-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021179-001 RENAGEL 400MG TABLET / ORAL AB RLD 2000-07-12 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N021179-002 RENAGEL 800MG TABLET / ORAL AB RLD, RS 2000-07-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021179-001 RENAGEL 400MG TABLET / ORAL AB RLD 2000-07-12 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N021179-002 RENAGEL 800MG TABLET / ORAL AB RLD, RS 2000-07-12 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021179-001 6733780 2020-10-18 Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N021179-002 6733780 2020-10-18 Drug product 74a2ff9319b5…2020-12-22 03:56 UTC 2020-12 N021179-001 6733780 2020-10-18 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021179-002 6733780 2020-10-18 Drug product 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021179-001 6733780 2020-10-18 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021179-002 6733780 2020-10-18 Drug product c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021179-001 6733780 2020-10-18 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021179-002 6733780 2020-10-18 Drug product 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021179-001 6733780 2020-10-18 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021179-002 6733780 2020-10-18 Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021179-001 6733780 2020-10-18 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021179-002 6733780 2020-10-18 Drug product ea99ee380514…
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SEVELAMER HYDROCHLORIDE ACTIVE INGREDIENT GLS2PGI8QG RENAGEL TABLET [GENZYME CORPORATION] 13 SEVELAMER ACTIVE MOIETY 941N5DUU5C RENAGEL TABLET [GENZYME CORPORATION] 13 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 RENAGEL TABLET [GENZYME CORPORATION] 13 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W RENAGEL TABLET [GENZYME CORPORATION] 13 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 RENAGEL TABLET [GENZYME CORPORATION] 13 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 RENAGEL TABLET [GENZYME CORPORATION] 13 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 RENAGEL TABLET [GENZYME CORPORATION] 13 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RENAGEL TABLET [GENZYME CORPORATION] 13 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP RENAGEL TABLET [GENZYME CORPORATION] 13 WATER INACTIVE INGREDIENT 059QF0KO0R RENAGEL TABLET [GENZYME CORPORATION] 13 SEVELAMER HYDROCHLORIDE ACTIVE INGREDIENT GLS2PGI8QG RENAGEL TABLET [ATLANTIC BIOLOGICALS CORPS] 3 SEVELAMER ACTIVE MOIETY 941N5DUU5C RENAGEL TABLET [ATLANTIC BIOLOGICALS CORPS] 3 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 RENAGEL TABLET [ATLANTIC BIOLOGICALS CORPS] 3 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W RENAGEL TABLET [ATLANTIC BIOLOGICALS CORPS] 3 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 RENAGEL TABLET [ATLANTIC BIOLOGICALS CORPS] 3 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 RENAGEL TABLET [ATLANTIC BIOLOGICALS CORPS] 3 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 RENAGEL TABLET [ATLANTIC BIOLOGICALS CORPS] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RENAGEL TABLET [ATLANTIC BIOLOGICALS CORPS] 3 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP RENAGEL TABLET [ATLANTIC BIOLOGICALS CORPS] 3 WATER INACTIVE INGREDIENT 059QF0KO0R RENAGEL TABLET [ATLANTIC BIOLOGICALS CORPS] 3 SEVELAMER HYDROCHLORIDE ACTIVE INGREDIENT GLS2PGI8QG RENAGEL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 SEVELAMER HYDROCHLORIDE ACTIVE INGREDIENT GLS2PGI8QG RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SEVELAMER ACTIVE MOIETY 941N5DUU5C RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 SEVELAMER ACTIVE MOIETY 941N5DUU5C RENAGEL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 RENAGEL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 RENAGEL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYPROMELLOSE 2910 (15 CPS) INACTIVE INGREDIENT 36SFW2JZ0W RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W RENAGEL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 HYPROMELLOSE 2910 (5 CPS) INACTIVE INGREDIENT R75537T0T4 RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 HYPROMELLOSE 2910 (5 MPA.S) INACTIVE INGREDIENT R75537T0T4 RENAGEL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 RENAGEL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 RENAGEL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP RENAGEL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1 WATER INACTIVE INGREDIENT 059QF0KO0R RENAGEL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R RENAGEL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 58468-0021-1 58468002101 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58468-0021-1) 2008-06-06 0000-00-00 No No Current