Cholestyramine

Product NDC
72162-1504
11-digit product format
721621504
Labeler code
72162
Product ID
72162-1504_cf7f5e91-db59-472d-aff1-d7d2650a8cef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cholestyramine
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077204
Marketing category
ANDA
Marketing start
2005-09-15
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

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
A077204-001CHOLESTYRAMINECHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-26
A077204-002CHOLESTYRAMINECHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077204-001AB
A077204-002AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077204-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-26caaa826d4ba7…
2026-08-18 06:07:402026-07A077204-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077204-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077204-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077204-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077204-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077204-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077204-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077204-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077204-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077204-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077204-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077204-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077204-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077204-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077204-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077204-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077204-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077204-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077204-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077204-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A077204-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077204-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077204-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077204-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077204-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077204-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077204-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077204-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077204-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077204-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077204-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077204-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077204-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077204-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077204-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077204-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077204-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077204-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077204-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-26bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077204-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077204-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077204-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077204-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077204-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077204-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077204-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077204-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077204-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077204-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077204-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077204-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077204-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077204-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077204-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077204-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077204-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077204-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077204-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077204-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077204-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077204-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077204-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077204-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077204-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077204-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077204-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077204-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077204-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077204-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077204-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077204-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077204-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077204-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077204-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077204-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077204-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077204-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077204-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077204-002AB1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
Cholestyramine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHOLESTYRAMINE4 g/9g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4B33BGI082Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
848943Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cc447b99-e654-42dd-8cf1-f9e7952a25cdAvailable on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-1504-2Cholestyramine378 g in 1 CANPOWDER, FOR SUSPENSION378100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1504-2GM - Gram72162-1504382c9769-1518-4fb9-9bd0-713e5b3a84c412024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1504CHOLESTYRAMINE POWDER, FOR SUSPENSION [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20230927_cc447b99-e654-42dd-8cf1-f9e7952a25cd.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CholestyramineCHOLESTYRAMINEBryant Ranch Prepackcc447b99-e654-42dd-8cf1-f9e7952a25cd2026-07-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077204
application number: ANDA077204
ndc (product): 72162-1504
CholestyramineCHOLESTYRAMINEBryant Ranch Prepack2998a314-deb2-4a02-afab-7e8c868888e22026-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077204
application number: ANDA077204
CholestyramineCHOLESTYRAMINEPar Health USA, LLCb0c65058-22c3-4f57-9b61-9bc6fcd6e2402026-06-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077204
application number: ANDA077204
QUESTRANCHOLESTYRAMINEEndo USA, Inc.362ddd91-a63f-4ec6-841a-75785dd208c82024-11-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077204
application number: ANDA077204

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848943cholestyramine resin 4 GM Powder for Oral SuspensionPSNcc447b99-e654-42dd-8cf1-f9e7952a25cd100
848943cholestyramine resin 4000 MG Powder for Oral SuspensionSCDcc447b99-e654-42dd-8cf1-f9e7952a25cd100
848943cholestyramine resin 4 GM per 9 GM Powder for Oral SuspensionSYcc447b99-e654-42dd-8cf1-f9e7952a25cd100
848943cholestyramine resin 4 GM Powder for Oral SuspensionSYcc447b99-e654-42dd-8cf1-f9e7952a25cd100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1504-272162150402378 g in 1 CAN (72162-1504-2) 378 g2023-09-26NoNoCurrent