Home NDC 59651-087 SEVELAMER HYDROCHLORIDE
Product NDC 59651-087
11-digit product format 596510087
Labeler code 59651
Product ID 59651-087_7a6f6abf-8a91-423e-8f2f-de1b3a019e7b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SEVELAMER HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA212599
Marketing category ANDA
Marketing start 2023-07-11
Substance SEVELAMER HYDROCHLORIDE
Active strength 400 mg/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 A212599-001 SEVELAMER HYDROCHLORIDE SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL BX 2023-07-11 A212599-002 SEVELAMER HYDROCHLORIDE SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL BX 2023-07-11
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 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 2026-02-19 14:30 UTC 2026-02 A212599-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL BX 2023-07-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212599-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL BX 2023-07-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212599-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL BX 2023-07-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212599-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL BX 2023-07-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212599-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL BX 2023-07-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A212599-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL BX 2023-07-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212599-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2023-07-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212599-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2023-07-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212599-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2023-07-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212599-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2023-07-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212599-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2023-07-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212599-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2023-07-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212599-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2023-07-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212599-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2023-07-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212599-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2023-07-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212599-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2023-07-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212599-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2023-07-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212599-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2023-07-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212599-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2023-07-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A212599-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2023-07-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212599-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2023-07-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212599-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2023-07-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212599-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2023-07-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212599-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2023-07-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212599-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2023-07-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212599-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2023-07-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212599-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2023-07-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A212599-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2023-07-11 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212599-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2023-07-11 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212599-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2023-07-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212599-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2023-07-11 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A212599-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2023-07-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212599-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2023-07-11 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A212599-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2023-07-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212599-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2023-07-11 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212599-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2023-07-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212599-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2023-07-11 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212599-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2023-07-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212599-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2023-07-11 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212599-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2023-07-11 a67488948f0b…
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 HYDROCHLORIDE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SEVELAMER HYDROCHLORIDE 400 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 857216 Internal RxNorm lookup 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 59651-087-36 SEVELAMER HYDROCHLORIDE 360 in 1 BOTTLE TABLET, FILM COATED 360 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-087 SEVELAMER HYDROCHLORIDE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 2 Current NDC, 1 package rows 20240126_d8729e42-dbbd-4954-9ce0-298743a15a06.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 59651-087-36 59651008736 360 TABLET, FILM COATED in 1 BOTTLE (59651-087-36) 2023-07-11 No No Current