Home NDC 72789-562-94 SEVELAMER CARBONATE
Product NDC 72789-562
Requested package NDC 72789-562-94
11-digit product format 727890562
Labeler code 72789
Product ID 72789-562_4faaca2e-237f-58ee-e063-6394a90acd4b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SEVELAMER CARBONATE
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA215998
Marketing category ANDA
Marketing start 2025-12-15
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 A215998-001 SEVELAMER CARBONATE SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2024-10-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215998-001 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 A215998-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2024-10-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215998-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2024-10-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215998-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2024-10-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215998-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2024-10-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215998-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2024-10-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215998-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2024-10-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215998-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2024-10-24 2680178bc6a6…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215998-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2024-10-24 d8e5a09893c0…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215998-001 SEVELAMER CARBONATE 800MG TABLET / ORAL AB 2024-10-24 a50c72e98297…
Observed Orange Book normalized TE history# 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 72789-562-94 SEVELAMER CARBONATE 270 in 1 BOTTLE, PLASTIC TABLET 270 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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72789-562-94 72789056294 270 TABLET in 1 BOTTLE, PLASTIC (72789-562-94) 270 tablet 2026-04-16 No No Current