Home NDC 68180-457 SEVELAMER CARBONATE
Product NDC 68180-457
11-digit product format 681800457
Labeler code 68180
Product ID 68180-457_9f0c0874-c84a-4989-a765-8b4c053d5b51
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SEVELAMER CARBONATE
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA201513
Marketing category ANDA
Marketing start 2022-12-01
Marketing end 0000-00-00
Substance SEVELAMER CARBONATE
Active strength 2 g/1
Pharmacologic classes Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 A201513-001 SEVELAMER CARBONATE SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL 2021-12-23 A201513-002 SEVELAMER CARBONATE SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL 2021-12-23
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 · 66 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 A201513-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL 2021-12-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A201513-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL 2021-12-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A201513-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL 2021-12-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A201513-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL 2021-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201513-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL 2021-12-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201513-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL 2021-12-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201513-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL 2021-12-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A201513-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL 2021-12-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201513-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL 2021-12-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201513-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL 2021-12-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201513-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL 2021-12-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201513-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL 2021-12-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201513-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL 2021-12-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201513-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL 2021-12-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201513-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL 2021-12-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201513-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL 2021-12-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201513-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL 2021-12-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201513-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL 2021-12-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201513-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL 2021-12-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201513-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL 2021-12-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201513-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL 2021-12-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A201513-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL 2021-12-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201513-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL 2021-12-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201513-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL 2021-12-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201513-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL 2021-12-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201513-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL 2021-12-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201513-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL 2021-12-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201513-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL 2021-12-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201513-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL 2021-12-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A201513-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL 2021-12-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201513-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2021-12-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201513-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2021-12-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201513-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2021-12-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A201513-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2021-12-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201513-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2021-12-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A201513-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2021-12-23 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A201513-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL AB 2021-12-23 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A201513-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL AB 2021-12-23 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201513-001 SEVELAMER CARBONATE 800MG/PACKET FOR SUSPENSION / ORAL 2021-12-23 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201513-002 SEVELAMER CARBONATE 2.4GM/PACKET FOR SUSPENSION / ORAL 2021-12-23 6a51e52b5d6a…
Observed Orange Book normalized TE history# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68180-457-90 68180045790 90 PACKET in 1 CARTON (68180-457-90) > 1 POWDER, FOR SUSPENSION in 1 PACKET (68180-457-01) 90 packet 2022-12-01 0000-00-00 No No Current