CHOLESTYRAMINE

Product NDC
50090-3845
11-digit product format
500903845
Labeler code
50090
Product ID
50090-3845_797b62fa-66a7-4292-92df-291fda5ad173
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHOLESTYRAMINE
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA202902
Marketing category
ANDA
Marketing start
2017-06-08
Marketing end
0000-00-00
Substance
CHOLESTYRAMINE
Active strength
4 g/5.5g
Pharmacologic classes
Bile Acid Sequestrant [EPC],Bile-acid Binding Activity [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-3845IInactivated by FDA2026-08-17
excluded packagepackage50090-384550090-3845-0IInactivated by FDA2026-08-17

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 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-3845-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-3845-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50090-3845-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50090-3845-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50090-3845-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50090-3845-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50090-3845-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50090-3845-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50090-3845-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50090-3845-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50090-3845-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50090-3845-0557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50090-3845-08af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50090-3845-0834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50090-3845-01332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage50090-3845-0fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage50090-3845-086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage50090-3845-0bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage50090-3845-08dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage50090-3845-0e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage50090-3845-09bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202902-001CHOLESTYRAMINE LIGHTCHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-25
A202902-002CHOLESTYRAMINE LIGHTCHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2017-04-25

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A202902-001AB
A202902-002AB

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-25caaa826d4ba7…
2026-08-18 06:07:402026-07A202902-002CHOLESTYRAMINE LIGHTEQ 4GM RESIN/PACKETPOWDER / ORALAB2017-04-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-2579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-25301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-251e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-258072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-255c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-255d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-254b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-2574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-25bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-25782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-2587673890dc5c…
2021-03-12 10:30 UTC2021-03A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-255aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-258869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-25c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-253f01610625f2…
2019-09-15 20:21 UTC2019-09A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-25b00525d2431f…
2019-07-19 19:46 UTC2019-07A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-25ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-256a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-251c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-25ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-25a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-259b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-25a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-253f0d92c62455…
2023-05-13 08:27 UTC2023-05A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-25053a50430f4f…
2023-01-26 05:58 UTC2023-01A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-253bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-253a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202902-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2017-04-25f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202902-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202902-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202902-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202902-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202902-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202902-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202902-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202902-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202902-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202902-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202902-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202902-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202902-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202902-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202902-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202902-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202902-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202902-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202902-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202902-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202902-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202902-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202902-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A202902-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202902-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202902-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202902-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A202902-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202902-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202902-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202902-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202902-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202902-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202902-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202902-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202902-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A202902-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A202902-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202902-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202902-001AB1f41ea6bd6efb…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bafdcfac-da3a-43c4-81f4-296b60084636Product name620250623

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3845-02020-01-31C16284748780-19d75b9cf-e92d-f424-e053-dadaa90a57ceCholestyramine for Oral Suspension USP, Light

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3845-0CHOLESTYRAMINE60 in 1 CARTONPOWDER, FOR SUSPENSION601
50090-3845-0CHOLESTYRAMINE5.5 g in 1 POUCHPOWDER, FOR SUSPENSION5.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3845CHOLESTYRAMINE POWDER, FOR SUSPENSION [A-S MEDICATION SOLUTIONS]1Legacy NDC, 2 package rows20181206_e7443ed0-6fbc-47bd-898d-0d990546536c.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CHOLESTYRAMINECHOLESTYRAMINEZydus Lifesciences Limitedd7c6bc5e-1916-43bf-b943-98f00f41b8de2024-01-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202902
application number: ANDA202902
CHOLESTYRAMINECHOLESTYRAMINEZydus Pharmaceuticals (USA) Inc.2dcf7652-0c3e-4bc3-abfd-20a5b3d2a4f42024-01-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202902
application number: ANDA202902

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1801279cholestyramine Sugar-Free 4 GM Powder for Oral SuspensionPSNe7443ed0-6fbc-47bd-898d-0d990546536c1
1801279Sugar-Free cholestyramine resin 4000 MG Powder for Oral SuspensionSCDe7443ed0-6fbc-47bd-898d-0d990546536c1
1801279cholestyramine Sugar-Free 4 GM Powder for Oral SuspensionSYe7443ed0-6fbc-47bd-898d-0d990546536c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-3845-05009038450060 in 1 CARTONHistorical