Home NDC 0115-1320 Colesevelam Hydrochloride
Product NDC 0115-1320
11-digit product format 001151320
Labeler code 0115
Product ID 0115-1320_6fbde16a-69db-42e0-9e63-86c1116ae99f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name COLESEVELAM HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA091600
Marketing category ANDA
Marketing start 2018-05-17
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 A091600-001 COLESEVELAM HYDROCHLORIDE COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091600-001 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.
Product history page 1 of 2 · 42 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 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091600-001 COLESEVELAM HYDROCHLORIDE 625MG TABLET / ORAL AB 2018-05-16 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Colesevelam Hydrochloride
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 0115-1320-19 Colesevelam Hydrochloride 180 in 1 BOTTLE TABLET, FILM COATED 180 18
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0115-1320 COLESEVELAM HYDROCHLORIDE TABLET, COATED [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 17 Current NDC, Legacy NDC, 1 package rows 20241120_f5306376-e7f2-44ad-8250-635b95428a7c.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 Marketing start Marketing end Sample Exclude flag Status 0115-1320-19 00115132019 180 TABLET, FILM COATED in 1 BOTTLE (0115-1320-19) 2018-05-17 0000-00-00 No No Current