Home NDC 33342-288 SEVELAMER CARBONATE
Product NDC 33342-288
11-digit product format 333420288
Labeler code 33342
Product ID 33342-288_c67610dd-5838-4acb-99c7-e66f507f1fc4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SEVELAMER CARBONATE
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA207291
Marketing category ANDA
Marketing start 2024-04-26
Substance SEVELAMER CARBONATE
Active strength .8 g/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 42 .
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 A207291-001 SEVELAMER CARBONATE SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2024-04-25 A207291-002 SEVELAMER CARBONATE SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2024-04-25
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.
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 2026-08-18 06:07:40 2026-07 A207291-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2024-04-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207291-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2024-04-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207291-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2024-04-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207291-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2024-04-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207291-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2024-04-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207291-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2024-04-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207291-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2024-04-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207291-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2024-04-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207291-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2024-04-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207291-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2024-04-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207291-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2024-04-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207291-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2024-04-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207291-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2024-04-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207291-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2024-04-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207291-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2024-04-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207291-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2024-04-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207291-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2024-04-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207291-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2024-04-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207291-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2024-04-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207291-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2024-04-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207291-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2024-04-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207291-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2024-04-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207291-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2024-04-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207291-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2024-04-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207291-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2024-04-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207291-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2024-04-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207291-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2024-04-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207291-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2024-04-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207291-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2024-04-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A207291-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2024-04-25 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207291-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2024-04-25 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207291-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2024-04-25 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base SEVELAMER CARBONATE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SEVELAMER CARBONATE .8 g/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 33342-288-68 SEVELAMER CARBONATE 90 in 1 CARTON POWDER, FOR SUSPENSION 90 2 33342-288-68 SEVELAMER CARBONATE 1 in 1 PACKET POWDER, FOR SUSPENSION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-288 SEVELAMER CARBONATE POWDER, FOR SUSPENSION [MACLEODS PHARMACEUTICALS LIMITED] 1 Current NDC, 2 package rows 20240514_48dbd7a7-32c7-45c1-ac8b-c478cf3282a6.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 · 2 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 33342-288-68 33342028868 90 PACKET in 1 CARTON (33342-288-68) / 1 POWDER, FOR SUSPENSION in 1 PACKET 90 packet 2024-04-26 No No Current