Home NDC 64380-881 SEVELAMER CARBONATE
Product NDC 64380-881
11-digit product format 643800881
Labeler code 64380
Product ID 64380-881_f0d25733-65a5-4143-a027-3412ff7a167d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sevelamer carbonate
Dosage form FOR SUSPENSION
Route ORAL
Labeler Strides Pharma Science Limited
Application ANDA211917
Marketing category ANDA
Marketing start 2024-02-02
Substance SEVELAMER CARBONATE
Active strength 2400 mg/2790mg
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 A211917-001 SEVELAMER CARBONATE SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 A211917-002 SEVELAMER CARBONATE SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB RS 2023-09-08
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 2 · 42 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 2026-08-18 06:07:40 2026-07 A211917-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211917-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB RS 2023-09-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211917-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211917-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211917-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211917-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211917-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211917-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211917-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211917-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211917-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211917-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211917-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211917-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211917-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211917-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211917-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211917-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211917-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211917-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211917-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211917-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211917-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211917-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211917-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211917-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211917-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211917-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211917-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A211917-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211917-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211917-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211917-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A211917-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211917-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A211917-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211917-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211917-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211917-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211917-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2023-09-08 9b2671bbb829…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 2400 mg/2790mg
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 64380-881-00 SEVELAMER CARBONATE 2400 mg in 1 PACKET FOR SUSPENSION 2400 6 64380-881-80 SEVELAMER CARBONATE 90 in 1 CARTON FOR SUSPENSION 90 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64380-881 SEVELAMER CARBONATE FOR SUSPENSION [STRIDES PHARMA SCIENCE LIMITED] 6 Current NDC, 2 package rows 20240224_c17bff97-8347-43f8-822e-1cb9736562b6.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 Units Marketing start Sample Exclude flag Status 64380-881-00 64380088100 2400 mg in 1 PACKET 2400 mg Historical 64380-881-80 64380088180 90 PACKET in 1 CARTON (64380-881-80) / 2400 mg in 1 PACKET (64380-881-00) 90 packet 2024-02-02 No No Current