Home NDC 51224-011 Cholestyramine
Product NDC 51224-011
11-digit product format 512240011
Labeler code 51224
Product ID 51224-011_94d7bc24-2f81-463b-b646-92fbf6641f71
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Cholestyramine
Dosage form POWDER, FOR SUSPENSION
Route ORAL
Labeler TAGI Pharma, Inc.
Application ANDA209597
Marketing category ANDA
Marketing start 2021-03-10
Marketing end 2026-11-30
Substance CHOLESTYRAMINE
Active strength 4 g/8.3g
Pharmacologic classes Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]
NDC exclude flag No
Current FDA listing Yes 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 A209597-001 CHOLESTYRAMINE CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2021-03-09 A209597-002 CHOLESTYRAMINE CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2021-03-09
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.
Product history page 1 of 2 · 68 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 2026-02-19 14:30 UTC 2026-02 A209597-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2021-03-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209597-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2021-03-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209597-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2021-03-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209597-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2021-03-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209597-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2021-03-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209597-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2021-03-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209597-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2021-03-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209597-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2021-03-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209597-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2021-03-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209597-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2021-03-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209597-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2021-03-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209597-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2021-03-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209597-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2021-03-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209597-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2021-03-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209597-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2021-03-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209597-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2021-03-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209597-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2021-03-09 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209597-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2021-03-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209597-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2021-03-09 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209597-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2021-03-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209597-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2021-03-09 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209597-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2021-03-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209597-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2021-03-09 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209597-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2021-03-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209597-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2021-03-09 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209597-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2021-03-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209597-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2021-03-09 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209597-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2021-03-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209597-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2021-03-09 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209597-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2021-03-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209597-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2021-03-09 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A209597-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2021-03-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209597-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2021-03-09 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A209597-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2021-03-09 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A209597-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2021-03-09 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A209597-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2021-03-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209597-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2021-03-09 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A209597-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2021-03-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209597-001 CHOLESTYRAMINE EQ 4GM RESIN/PACKET POWDER / ORAL AB 2021-03-09 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209597-002 CHOLESTYRAMINE EQ 4GM RESIN/SCOOPFUL POWDER / ORAL AB 2021-03-09 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 68 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Cholestyramine Active Ingredients# Ingredient, Strength table Ingredient Strength CHOLESTYRAMINE 4 g/8.3g
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 51224-011-10 Cholestyramine 348.6 g in 1 CAN POWDER, FOR SUSPENSION 348.6 4 51224-011-20 Cholestyramine 60 in 1 CARTON POWDER, FOR SUSPENSION 60 4 51224-011-20 Cholestyramine 8.3 g in 1 POUCH POWDER, FOR SUSPENSION 8.3 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51224-011 CHOLESTYRAMINE POWDER, FOR SUSPENSION [TAGI PHARMA, INC.] 4 Current NDC, Legacy NDC, 3 package rows 20250424_06261db5-1435-4b91-8b54-71bfcfb1368c.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 51224-011-10 51224001110 348.6 g in 1 CAN (51224-011-10) 348.6 g 2021-03-10 2026-11-30 No No Current 51224-011-20 51224001120 60 POUCH in 1 CARTON (51224-011-20) / 8.3 g in 1 POUCH 60 pouch 2021-03-10 2026-11-30 No No Current