Home NDC 50742-284 Colestipol Hydrochloride
Product NDC 50742-284
11-digit product format 507420284
Labeler code 50742
Product ID 50742-284_f784d09d-69b6-4e7b-a1eb-8b7e839cd4db
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Colestipol Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Ingenus Pharmaceuticals, LLC
Application ANDA217462
Marketing category ANDA
Marketing start 2024-12-03
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 A217462-001 COLESTIPOL HYDROCHLORIDE COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2024-12-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217462-001 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 A217462-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2024-12-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217462-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2024-12-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217462-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2024-12-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217462-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2024-12-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217462-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2024-12-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217462-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2024-12-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217462-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2024-12-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217462-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2024-12-03 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217462-001 COLESTIPOL HYDROCHLORIDE 1GM TABLET / ORAL AB 2024-12-03 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 50742-284-12 Colestipol Hydrochloride 120 in 1 BOTTLE TABLET, FILM COATED 120 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50742-284 COLESTIPOL HYDROCHLORIDE TABLET, FILM COATED [INGENUS PHARMACEUTICALS, LLC] 1 Current NDC, 1 package rows 20241219_3fa27483-8346-4145-81c0-5527204d7d68.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 50742-284-12 50742028412 120 TABLET, FILM COATED in 1 BOTTLE (50742-284-12) 2024-12-03 No No Current