Home NDC 0115-5211 COLESTIPOL HYDROCHLORIDE
Product NDC 0115-5211
11-digit product format 001155211
Labeler code 0115
Product ID 0115-5211_4ec79132-daa8-4439-bbd2-6f8c8c020e4f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name COLESTIPOL HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA077510
Marketing category ANDA
Marketing start 2021-08-17
Substance COLESTIPOL HYDROCHLORIDE
Active strength 1 g/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 A077510-001 COLESTIPOL HYDROCHLORIDE COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2006-10-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077510-001 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 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2006-10-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2006-10-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2006-10-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2006-10-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2006-10-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2006-10-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2006-10-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2006-10-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2006-10-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2006-10-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2006-10-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2006-10-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2006-10-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2006-10-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2006-10-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2006-10-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2006-10-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2006-10-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2006-10-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2006-10-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2006-10-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2006-10-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2006-10-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2006-10-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2006-10-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2006-10-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2006-10-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2006-10-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2006-10-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2006-10-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2006-10-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2006-10-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2006-10-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2006-10-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2006-10-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2006-10-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2006-10-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2006-10-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2006-10-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077510-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB RS 2006-10-24 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 COLESTIPOL HYDROCHLORIDE
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength COLESTIPOL HYDROCHLORIDE 1 g/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination X7D10K905G Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1048445 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 0115-5211-02 COLESTIPOL HYDROCHLORIDE 500 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 500 15 0115-5211-16 COLESTIPOL HYDROCHLORIDE 120 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 120 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded COLESTIPOL HYDROCHLORIDE ACTIVE INGREDIENT X7D10K905G COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 3 COLESTIPOL ACTIVE MOIETY K50N755924 COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 3 CELLACEFATE INACTIVE INGREDIENT F2O5O2OI9F COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 3 COPOVIDONE K25-31 INACTIVE INGREDIENT D9C330MD8B COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 3 DIBUTYL SEBACATE INACTIVE INGREDIENT 4W5IH7FLNY COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 3 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 3 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0115-5211 COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 14 Current NDC, Legacy NDC, 2 package rows 20250215_fa6c3e11-84e9-433d-aa74-7cd34336bbed.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 0115-5211-02 00115521102 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-5211-02) 2021-08-17 0000-00-00 No No Current 0115-5211-16 00115521116 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0115-5211-16) 2021-08-17 0000-00-00 No No Current