Home NDC 70771-1653 Colestipol hydrochloride
Product NDC 70771-1653
11-digit product format 707711653
Labeler code 70771
Product ID 70771-1653_e5237070-d3ba-4dd6-921d-7ec80d8bc251
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Colestipol hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Lifesciences Limited
Application ANDA215223
Marketing category ANDA
Marketing start 2022-05-04
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 A215223-001 COLESTIPOL HYDROCHLORIDE COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2022-03-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215223-001 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 A215223-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2022-03-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215223-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2022-03-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215223-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2022-03-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215223-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2022-03-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215223-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2022-03-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215223-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2022-03-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215223-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2022-03-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215223-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2022-03-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215223-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2022-03-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215223-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2022-03-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215223-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2022-03-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215223-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2022-03-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215223-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2022-03-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215223-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2022-03-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215223-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2022-03-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215223-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2022-03-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215223-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2022-03-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215223-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2022-03-10 4b0b4de00fa7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215223-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2022-03-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215223-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2022-03-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215223-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2022-03-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215223-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2022-03-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215223-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2022-03-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215223-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2022-03-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215223-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2022-03-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215223-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2022-03-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215223-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2022-03-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215223-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2022-03-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215223-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2022-03-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215223-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2022-03-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215223-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2022-03-10 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215223-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2022-03-10 a50c72e98297…
Observed Orange Book normalized TE history# 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 70771-1653-5 Colestipol hydrochloride 500 in 1 BOTTLE TABLET, FILM COATED 500 5 70771-1653-7 Colestipol hydrochloride 120 in 1 BOTTLE TABLET, FILM COATED 120 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70771-1653 COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] 5 Current NDC, Legacy NDC, 2 package rows 20241128_3b451f0b-5bd9-419a-afa2-a02eb0bbc45e.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 70771-1653-5 70771165305 500 TABLET, FILM COATED in 1 BOTTLE (70771-1653-5) 2022-05-04 0000-00-00 No No Current 70771-1653-7 70771165307 120 TABLET, FILM COATED in 1 BOTTLE (70771-1653-7) 2022-05-04 0000-00-00 No No Current