Home NDC 43598-478-90 Sevelamer Carbonate for Oral Suspension
Product NDC 43598-478
Requested package NDC 43598-478-90
11-digit product format 435980478
Labeler code 43598
Product ID 43598-478_85e37025-d239-e504-38a0-c2db7ffa0100
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sevelamer Carbonate for Oral Suspension
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Dr. Reddys Laboratories Inc
Application ANDA210464
Marketing category ANDA
Marketing start 2018-10-25
Substance SEVELAMER CARBONATE
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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210464-001 SEVELAMER CARBONATE SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 A210464-002 SEVELAMER CARBONATE SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2018-10-25
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 · 82 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 A210464-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210464-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210464-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210464-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210464-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210464-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210464-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210464-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210464-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210464-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210464-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210464-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210464-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210464-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210464-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210464-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210464-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210464-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210464-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A210464-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210464-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210464-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210464-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210464-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210464-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210464-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210464-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A210464-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210464-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210464-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210464-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A210464-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210464-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A210464-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210464-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A210464-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210464-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A210464-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210464-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A210464-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2018-10-25 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Sevelamer Carbonate for Oral Suspension
Listing expiration 2026-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 861370 Internal RxNorm lookup 861375 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 43598-478-01 Sevelamer Carbonate for Oral Suspension 1 in 1 PACKET POWDER, FOR SUSPENSION 1 3 43598-478-90 Sevelamer Carbonate for Oral Suspension 90 in 1 CARTON POWDER, FOR SUSPENSION 90 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43598-478 SEVELAMER CARBONATE FOR ORAL SUSPENSION POWDER, FOR SUSPENSION [DR. REDDYS LABORATORIES INC] 3 Current NDC, Legacy NDC, 2 package rows 20200707_de172c3d-17eb-3489-35fb-370a0893b663.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43598-478-90 43598047890 90 PACKET in 1 CARTON (43598-478-90) / 1 POWDER, FOR SUSPENSION in 1 PACKET (43598-478-01) 90 packet 2018-10-25 0000-00-00 No No Current