Home NDC 70710-2058 Sevelamer Hydrochloride
Product NDC 70710-2058
11-digit product format 707102058
Labeler code 70710
Product ID 70710-2058_f9b9e637-d236-4bc0-afca-bbbf1b1747ab
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sevelamer Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA218966
Marketing category ANDA
Marketing start 2025-03-01
Substance SEVELAMER HYDROCHLORIDE
Active strength 800 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218966-001 SEVELAMER HYDROCHLORIDE SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2025-02-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A218966-001 AB
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.
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 A218966-001 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2025-02-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218966-001 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2025-02-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218966-001 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2025-02-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218966-001 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2025-02-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218966-001 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2025-02-03 b8a1b40f171c…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218966-001 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2025-02-03 a50c72e98297…
Observed Orange Book normalized TE history# 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 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 70710-2058-8 Sevelamer Hydrochloride 180 in 1 BOTTLE TABLET, FILM COATED 180 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70710-2058 SEVELAMER HYDROCHLORIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] 1 Current NDC, 1 package rows 20250302_ddecb552-5882-4e44-8fa7-37c9234dd1b9.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 70710-2058-8 70710205808 180 TABLET, FILM COATED in 1 BOTTLE (70710-2058-8) 2025-03-01 No No Current