Home NDC 68462-447 sevelamer hydrochloride
Product NDC 68462-447
11-digit product format 684620447
Labeler code 68462
Product ID 68462-447_5b27539f-4664-4a6b-abe4-2abcc7ad2279
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sevelamer hydrochloride
Dosage form TABLET, FILM COATED
Route PARENTERAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA204724
Marketing category ANDA
Marketing start 2019-02-08
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 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 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 · 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 A204724-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2019-02-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 A204724-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2019-02-08 84e616aacf4f…2026-08-18 06:07:40 2026-07 A204724-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2019-02-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204724-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2019-02-08 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 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 · 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 68462-447-18 sevelamer hydrochloride 180 in 1 BOTTLE TABLET, FILM COATED 180 7 68462-447-30 sevelamer hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-447 SEVELAMER HYDROCHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 6 Current NDC, Legacy NDC, 2 package rows 20240104_2cd6512f-0edd-4a30-a4fa-aa996038633c.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 · 4 matching rows.
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 68462-447-18 68462044718 180 TABLET, FILM COATED in 1 BOTTLE (68462-447-18) 2019-02-08 0000-00-00 No No Current 68462-447-30 68462044730 30 TABLET, FILM COATED in 1 BOTTLE (68462-447-30) 2019-02-08 0000-00-00 No No Current