Home DailyMed a78ee8a3-e8b3-4dbc-99ca-4f60e2082804 National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 02:25:09 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 86 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 2026-09-14 22:38:34 2026-08 N022318-001 RENVELA 800MG/PACKET FOR SUSPENSION / ORAL RLD 2009-08-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022318-002 RENVELA 2.4GM/PACKET FOR SUSPENSION / ORAL RLD 2009-02-18 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022318-001 RENVELA 800MG/PACKET FOR SUSPENSION / ORAL RLD 2009-08-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022318-002 RENVELA 2.4GM/PACKET FOR SUSPENSION / ORAL RLD 2009-02-18 caaa826d4ba7…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…
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 · 86 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N022318-001 9095509 2030-12-06 Drug product 2016-01-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N022318-002 9095509 2030-12-06 Drug product 2016-01-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022318-001 9095509 2030-12-06 Drug product 2016-01-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022318-002 9095509 2030-12-06 Drug product 2016-01-13 caaa826d4ba7…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…
Observed Orange Book exclusivity history# 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 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.