Home NDC 59762-0450 Colestipol Hydrochloride
Product NDC 59762-0450
11-digit product format 597620450
Labeler code 59762
Product ID 59762-0450_1b610c4a-a8dc-4a10-bd7a-3e94ca49ee9c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Colestipol Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application NDA020222
Marketing category NDA AUTHORIZED GENERIC
Marketing start 1994-07-19
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 N020222-001 COLESTID COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB RLD 1994-07-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020222-001 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 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD 1994-07-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD 1994-07-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD 1994-07-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD 1994-07-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD 1994-07-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD 1994-07-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD 1994-07-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD 1994-07-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD 1994-07-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD 1994-07-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD 1994-07-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD 1994-07-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD 1994-07-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD 1994-07-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD 1994-07-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD 1994-07-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD, RS 1994-07-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD, RS 1994-07-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD, RS 1994-07-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD, RS 1994-07-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD, RS 1994-07-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD, RS 1994-07-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD, RS 1994-07-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD, RS 1994-07-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD, RS 1994-07-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD, RS 1994-07-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD, RS 1994-07-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD, RS 1994-07-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD 1994-07-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD 1994-07-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD 1994-07-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD 1994-07-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD 1994-07-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD 1994-07-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD 1994-07-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD 1994-07-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD 1994-07-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD 1994-07-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD 1994-07-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020222-001 COLESTID 1GM TABLET / ORAL AB RLD 1994-07-19 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 59762-0450-1 Colestipol Hydrochloride 120 in 1 BOTTLE TABLET 120 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded COLESTIPOL HYDROCHLORIDE ACTIVE INGREDIENT X7D10K905G COLESTIPOL HYDROCHLORIDE TABLET [GREENSTONE LLC] 4 COLESTIPOL ACTIVE MOIETY K50N755924 COLESTIPOL HYDROCHLORIDE TABLET [GREENSTONE LLC] 4 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ COLESTIPOL HYDROCHLORIDE TABLET [GREENSTONE LLC] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO COLESTIPOL HYDROCHLORIDE TABLET [GREENSTONE LLC] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 COLESTIPOL HYDROCHLORIDE TABLET [GREENSTONE LLC] 4 POVIDONES INACTIVE INGREDIENT FZ989GH94E COLESTIPOL HYDROCHLORIDE TABLET [GREENSTONE LLC] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 COLESTIPOL HYDROCHLORIDE TABLET [GREENSTONE LLC] 4 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 COLESTIPOL HYDROCHLORIDE TABLET [GREENSTONE LLC] 4 COLESTIPOL HYDROCHLORIDE ACTIVE INGREDIENT X7D10K905G COLESTIPOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] 2 COLESTIPOL ACTIVE MOIETY K50N755924 COLESTIPOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] 2 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ COLESTIPOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO COLESTIPOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 COLESTIPOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] 2 POVIDONES INACTIVE INGREDIENT FZ989GH94E COLESTIPOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 COLESTIPOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] 2 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 COLESTIPOL HYDROCHLORIDE TABLET [CARILION MATERIALS MANAGEMENT] 2 COLESTIPOL HYDROCHLORIDE ACTIVE INGREDIENT X7D10K905G COLESTIPOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 COLESTIPOL ACTIVE MOIETY K50N755924 COLESTIPOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ COLESTIPOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO COLESTIPOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 COLESTIPOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E COLESTIPOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 COLESTIPOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1 TRIACETIN INACTIVE INGREDIENT XHX3C3X673 COLESTIPOL HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59762-0450 COLESTIPOL HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.] 12 Current NDC, Legacy NDC, 1 package rows 20250515_dae7d51e-c117-4c8a-b018-45b01ae46100.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 Marketing end Sample Exclude flag Status 59762-0450-1 59762045001 120 TABLET in 1 BOTTLE (59762-0450-1) 120 tablet 1994-07-19 0000-00-00 No No Current