Home NDC 0115-1365 sevelamer carbonate
Product NDC 0115-1365
11-digit product format 001151365
Labeler code 0115
Product ID 0115-1365_b673720f-b62b-4afc-ac25-cb2ac4cf326f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sevelamer carbonate
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA211316
Marketing category ANDA
Marketing start 2020-11-20
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 A211316-001 SEVELAMER CARBONATE SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 A211316-002 SEVELAMER CARBONATE SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20
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 · 72 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 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2020-11-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211316-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL 2020-11-20 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211316-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL 2020-11-20 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 70 observed states.
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 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 0115-1365-29 sevelamer carbonate 90 in 1 CARTON POWDER, FOR SUSPENSION 90 11 0115-1365-30 sevelamer carbonate 1 in 1 PACKET POWDER, FOR SUSPENSION 1 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0115-1365 SEVELAMER CARBONATE POWDER, FOR SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 11 Current NDC, Legacy NDC, 2 package rows 20240101_da5239fe-060b-4469-95ac-173adec43b9c.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 Marketing end Sample Exclude flag Status 0115-1365-29 00115136529 90 PACKET in 1 CARTON (0115-1365-29) / 1 POWDER, FOR SUSPENSION in 1 PACKET (0115-1365-30) 90 packet 2020-11-20 0000-00-00 No No Current 0115-1365-30 00115136530 1 in 1 PACKET Historical