Home NDC 70748-172 Sevelamer hydrochloride
Product NDC 70748-172
11-digit product format 707480172
Labeler code 70748
Product ID 70748-172_efda61ea-6afc-4066-bc1c-1004f4152811
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sevelamer hydrochloride
Dosage form TABLET
Route ORAL
Labeler Lupin Pharmaceuticals, Inc.
Application ANDA213145
Marketing category ANDA
Marketing start 2022-02-25
Marketing end 0000-00-00
Substance SEVELAMER HYDROCHLORIDE
Active strength 400 mg/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 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 A213145-001 SEVELAMER HYDROCHLORIDE SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-06-16 A213145-002 SEVELAMER HYDROCHLORIDE SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2021-06-16
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 · 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 2026-02-19 14:30 UTC 2026-02 A213145-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-06-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A213145-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2021-06-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213145-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-06-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A213145-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2021-06-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A213145-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-06-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A213145-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2021-06-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213145-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-06-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A213145-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2021-06-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213145-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-06-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A213145-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2021-06-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213145-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-06-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A213145-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2021-06-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213145-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-06-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A213145-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2021-06-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213145-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-06-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A213145-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2021-06-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213145-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-06-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A213145-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2021-06-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A213145-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-06-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A213145-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2021-06-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213145-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-06-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A213145-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2021-06-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213145-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-06-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A213145-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2021-06-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213145-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-06-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A213145-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2021-06-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A213145-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-06-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A213145-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2021-06-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213145-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-06-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A213145-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2021-06-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A213145-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-06-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A213145-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2021-06-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A213145-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-06-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A213145-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2021-06-16 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A213145-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-06-16 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A213145-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2021-06-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A213145-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-06-16 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A213145-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2021-06-16 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213145-001 SEVELAMER HYDROCHLORIDE 400MG TABLET / ORAL AB 2021-06-16 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A213145-002 SEVELAMER HYDROCHLORIDE 800MG TABLET / ORAL AB 2021-06-16 6a51e52b5d6a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70748-172 SEVELAMER HYDROCHLORIDE TABLET [LUPIN PHARMACEUTICALS, INC.] 6 Legacy NDC 20220303_a56c857e-bc39-484c-908d-f5957857efbb.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70748-172-27 70748017227 360 TABLET in 1 BOTTLE (70748-172-27) 360 tablet 2022-02-25 0000-00-00 No No Current