Home NDC 60687-715 Colestipol Hydrochloride
Product NDC 60687-715
11-digit product format 606870715
Labeler code 60687
Product ID 60687-715_401f73b1-98f5-b6d1-e063-6394a90acf6e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Colestipol Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler American Health Packaging
Application ANDA077510
Marketing category ANDA
Marketing start 2023-05-10
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 2026-12-31 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 60687-715-11 Colestipol Hydrochloride 1 in 1 BLISTER PACK TABLET, FILM COATED 1 5 60687-715-21 Colestipol Hydrochloride 30 in 1 CARTON TABLET, FILM COATED 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60687-715 COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] 4 Current NDC, 2 package rows 20250104_153e9154-1804-4d73-94b7-a31a1d37c420.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 Sample Exclude flag Status 60687-715-11 60687071511 1 in 1 BLISTER PACK Historical 60687-715-21 60687071521 30 BLISTER PACK in 1 CARTON (60687-715-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-715-11) 30 blister pack 2023-05-10 No No Current