Home NDC 70771-1368 COLESEVELAM
Product NDC 70771-1368
11-digit product format 707711368
Labeler code 70771
Product ID 70771-1368_8bd17f3d-9ca2-4ce2-93a1-b4e9d8571079
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name COLESEVELAM
Dosage form TABLET
Route ORAL
Labeler Zydus Lifesciences Limited
Application ANDA207765
Marketing category ANDA
Marketing start 2019-10-11
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 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 16 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A207765-001 COLESEVELAM HYDROCHLORIDE COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207765-001 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 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207765-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2019-10-07 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base COLESEVELAM
Listing expiration 2026-12-31 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70771-1368-0 COLESEVELAM 1000 in 1 BOTTLE TABLET 1000 5 70771-1368-2 COLESEVELAM 10 in 1 BLISTER PACK TABLET 10 5 70771-1368-4 COLESEVELAM 10 in 1 CARTON TABLET 10 5 70771-1368-8 COLESEVELAM 180 in 1 BOTTLE TABLET 180 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70771-1368 COLESEVELAM TABLET [ZYDUS LIFESCIENCES LIMITED] 5 Current NDC, Legacy NDC, 4 package rows 20241130_090eabd5-acd3-43ed-a05b-52f1f3773a93.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 · 2 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 70771-1368-0 70771136800 1000 TABLET in 1 BOTTLE (70771-1368-0) 1000 tablet 2019-10-11 0000-00-00 No No Current 70771-1368-2 70771136802 10 in 1 BLISTER PACK Historical 70771-1368-4 70771136804 10 BLISTER PACK in 1 CARTON (70771-1368-4) / 10 TABLET in 1 BLISTER PACK (70771-1368-2) 10 blister pack 2019-10-11 0000-00-00 No No Current 70771-1368-8 70771136808 180 TABLET in 1 BOTTLE (70771-1368-8) 180 tablet 2019-10-11 0000-00-00 No No Current