Home NDC 33342-293 Cholestyramine
Product NDC 33342-293
11-digit product format 333420293
Labeler code 33342
Product ID 33342-293_96fd22fa-700e-4d41-b433-617dc457c2b3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cholestyramine
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA207294
Marketing category ANDA
Marketing start 2024-11-21
Substance CHOLESTYRAMINE
Active strength 4 g/9g
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 33342-293 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 33342-293 33342-293-71 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 33342-293 33342-293-70 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207294-001 CHOLESTYRAMINE CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2024-11-21 A207294-002 CHOLESTYRAMINE CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2024-11-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 2026-02-19 14:30 UTC 2026-02 A207294-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2024-11-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207294-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2024-11-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207294-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2024-11-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207294-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2024-11-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207294-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2024-11-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207294-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2024-11-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207294-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2024-11-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207294-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2024-11-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207294-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2024-11-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207294-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2024-11-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207294-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2024-11-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207294-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2024-11-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207294-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2024-11-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207294-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2024-11-21 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207294-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2024-11-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207294-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2024-11-21 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Cholestyramine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CHOLESTYRAMINE 4 g/9g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4B33BGI082 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 848943 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 33342-293-70 Cholestyramine 60 in 1 CARTON POWDER, FOR SUSPENSION 60 4 33342-293-71 Cholestyramine 378 g in 1 JAR POWDER, FOR SUSPENSION 378 4 33342-293-75 Cholestyramine 9 g in 1 POUCH POWDER, FOR SUSPENSION 9 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-293 CHOLESTYRAMINE POWDER, FOR SUSPENSION [MACLEODS PHARMACEUTICALS LIMITED] 1 Current NDC, 3 package rows 20250131_8cbb1ed2-66cc-485d-a4b1-920f89fb6b3b.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 Units Marketing start Sample Exclude flag Status 33342-293-70 33342029370 60 POUCH in 1 CARTON (33342-293-70) / 9 g in 1 POUCH (33342-293-75) 60 pouch 2024-11-21 No No Current 33342-293-71 33342029371 378 g in 1 JAR (33342-293-71) 378 g 2024-11-21 No No Current 33342-293-75 33342029375 9 g in 1 POUCH 9 g Historical