Home NDC 68382-619 Colesevelam
Product NDC 68382-619
11-digit product format 683820619
Labeler code 68382
Product ID 68382-619_bf6a10ac-0317-4804-a504-cd00e522dc65
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Colesevelam
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
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 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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68382-619-10 Colesevelam 1000 in 1 BOTTLE TABLET, FILM COATED 1000 6 68382-619-28 Colesevelam 180 in 1 BOTTLE TABLET, FILM COATED 180 6 68382-619-30 Colesevelam 10 in 1 BLISTER PACK TABLET, FILM COATED 10 6 68382-619-77 Colesevelam 10 in 1 CARTON TABLET, FILM COATED 10 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68382-619 COLESEVELAM TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] 5 Current NDC, Legacy NDC, 4 package rows 20230917_6a26e745-7e38-4af0-9bcc-566b2812df75.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 68382-619-10 68382061910 1000 TABLET, FILM COATED in 1 BOTTLE (68382-619-10) 2019-10-11 0000-00-00 No No Current 68382-619-28 68382061928 180 TABLET, FILM COATED in 1 BOTTLE (68382-619-28) 2019-10-11 0000-00-00 No No Current 68382-619-30 68382061930 10 in 1 BLISTER PACK Historical 68382-619-77 68382061977 10 BLISTER PACK in 1 CARTON (68382-619-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68382-619-30) 10 blister pack 2019-10-11 0000-00-00 No No Current