Home NDC 68475-010 Sevelamer carbonate
Product NDC 68475-010
11-digit product format 684750010
Labeler code 68475
Product ID 68475-010_d3c74ca1-7175-40a4-b96f-f864b7f47846
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sevelamer carbonate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Navinta LLC
Application ANDA219931
Marketing category ANDA
Marketing start 2025-11-01
Substance SEVELAMER CARBONATE
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 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 A219931-001 SEVELAMER CARBONATE SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2025-10-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219931-001 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 A219931-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2025-10-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219931-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2025-10-27 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219931-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2025-10-27 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A219931-001 AB 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A219931-001 AB 1 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219931-001 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Sevelamer carbonate
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SEVELAMER CARBONATE 800 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9YCX42I8IU Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 749206 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 68475-010-01 Sevelamer carbonate 30 in 1 BOTTLE TABLET, FILM COATED 30 2 68475-010-02 Sevelamer carbonate 270 in 1 BOTTLE TABLET, FILM COATED 270 2 68475-010-03 Sevelamer carbonate 180 in 1 BOTTLE TABLET, FILM COATED 180 2
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 · 2 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 68475-010-01 68475001001 30 TABLET, FILM COATED in 1 BOTTLE (68475-010-01) 2025-11-01 No No Current 68475-010-02 68475001002 270 TABLET, FILM COATED in 1 BOTTLE (68475-010-02) 2025-11-01 No No Current 68475-010-03 68475001003 180 TABLET, FILM COATED in 1 BOTTLE (68475-010-03) 2026-01-02 No No Current