Home NDC 69452-493 COLESEVELAM HYDROCHLORIDE
Product NDC 69452-493
11-digit product format 694520493
Labeler code 69452
Product ID 69452-493_4aa52a76-fe49-5557-e063-6294a90ace04
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name colesevelam hydrochloride
Dosage form TABLET
Route ORAL
Labeler Bionpharma Inc.
Application ANDA208670
Marketing category ANDA
Marketing start 2026-02-12
Substance COLESEVELAM HYDROCHLORIDE
Active strength 625 mg/1
Pharmacologic classes Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208670-001 COLESEVELAM HYDROCHLORIDE COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208670-001 AB
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 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208670-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-09-13 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base COLESEVELAM HYDROCHLORIDE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength COLESEVELAM HYDROCHLORIDE 625 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination P4SG24WI5Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 866910 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 69452-493-25 COLESEVELAM HYDROCHLORIDE 180 in 1 BOTTLE TABLET 180 1
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 69452-493-25 69452049325 180 TABLET in 1 BOTTLE (69452-493-25) 180 tablet 2026-02-12 No No Current