Cholestyramine

Product NDC
63629-2162
11-digit product format
636292162
Labeler code
63629
Product ID
63629-2162_058a1e41-eec4-4899-8767-8a5504c6d0b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cholestyramine
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077203
Marketing category
ANDA
Marketing start
2005-09-15
Substance
CHOLESTYRAMINE
Active strength
4 g/5g
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
A077203-001CHOLESTYRAMINE LIGHTCHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-26
A077203-002CHOLESTYRAMINE LIGHTCHOLESTYRAMINEEQ 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
A077203-001AB
A077203-002AB

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 06:07:402026-07A077203-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-26caaa826d4ba7…
2026-08-18 06:07:402026-07A077203-002CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077203-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077203-002CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077203-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077203-002CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A077203-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077203-002CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077203-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077203-002CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077203-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077203-002CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077203-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077203-002CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077203-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077203-002CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077203-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077203-002CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077203-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077203-002CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077203-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A077203-002CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077203-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077203-002CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077203-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077203-002CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077203-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077203-002CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077203-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-268072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077203-002CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077203-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-265c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077203-002CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077203-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-265d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077203-002CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077203-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-264b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077203-002CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077203-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-2674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077203-002CHOLESTYRAMINE LIGHTEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2005-08-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077203-001CHOLESTYRAMINE LIGHTEQ 4GM RESIN/PACKETPOWDER / ORALAB2005-08-26bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077203-002CHOLESTYRAMINE LIGHTEQ 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 06:07:402026-07A077203-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077203-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077203-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077203-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077203-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077203-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077203-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077203-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077203-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077203-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077203-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077203-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077203-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077203-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077203-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077203-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077203-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077203-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077203-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077203-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077203-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077203-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077203-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077203-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077203-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077203-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077203-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077203-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077203-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077203-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077203-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077203-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077203-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077203-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077203-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077203-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077203-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077203-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A077203-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A077203-002AB1bb7c543d1eb4…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHOLESTYRAMINE4 g/5g

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
1801279Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b26a13e9-42a2-4869-a00a-672bb1ac4742Available 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
63629-2162-1Cholestyramine210 g in 1 CANPOWDER, FOR SUSPENSION210104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2162-1GM - Gram63629-2162688aceac-5e38-4c26-a2a2-3ccd5b5e5d6c12021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2162CHOLESTYRAMINE POWDER, FOR SUSPENSION [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 1 package rows20231202_b26a13e9-42a2-4869-a00a-672bb1ac4742.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 Prepackb26a13e9-42a2-4869-a00a-672bb1ac47422026-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077203
application number: ANDA077203
ndc (product): 63629-2162
CholestyramineCHOLESTYRAMINEPar Health USA, LLCb0c65058-22c3-4f57-9b61-9bc6fcd6e2402026-06-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077203
application number: ANDA077203
QUESTRANCHOLESTYRAMINEEndo USA, Inc.362ddd91-a63f-4ec6-841a-75785dd208c82024-11-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077203
application number: ANDA077203
CholestyramineCHOLESTYRAMINEBryant Ranch Prepackc58d6bd9-0273-4c16-8533-495170413d8c2024-08-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077203
application number: ANDA077203

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1801279cholestyramine Sugar-Free 4 GM Powder for Oral SuspensionPSNb26a13e9-42a2-4869-a00a-672bb1ac4742104
1801279Sugar-Free cholestyramine resin 4000 MG Powder for Oral SuspensionSCDb26a13e9-42a2-4869-a00a-672bb1ac4742104
1801279cholestyramine Sugar-Free 4 GM Powder for Oral SuspensionSYb26a13e9-42a2-4869-a00a-672bb1ac4742104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2162-163629216201210 g in 1 CAN (63629-2162-1) 210 g2005-09-150000-00-00NoNoCurrent