Home NDC 72603-817 COLESTIPOL HYDROCHLORIDE
Product NDC 72603-817
11-digit product format 726030817
Labeler code 72603
Product ID 72603-817_515f9c9d-c91c-f5ac-e063-6294a90a2f3d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name COLESTIPOL HYDROCHLORIDE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NorthStar Rx LLC
Application ANDA216517
Marketing category ANDA
Marketing start 2026-09-01
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A216517-001 COLESTIPOL HYDROCHLORIDE COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2023-03-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216517-001 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 2026-09-14 22:38:34 2026-08 A216517-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2023-03-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216517-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2023-03-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216517-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2023-03-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216517-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2023-03-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216517-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2023-03-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216517-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2023-03-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216517-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2023-03-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216517-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2023-03-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216517-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2023-03-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216517-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2023-03-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216517-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2023-03-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216517-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2023-03-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216517-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2023-03-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216517-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2023-03-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216517-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2023-03-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216517-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2023-03-10 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216517-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2023-03-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216517-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2023-03-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216517-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2023-03-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216517-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2023-03-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216517-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2023-03-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216517-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2023-03-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216517-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2023-03-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216517-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2023-03-10 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216517-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2023-03-10 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72603-817-01 72603081701 120 TABLET, FILM COATED in 1 BOTTLE (72603-817-01) 2026-09-01 No No Current