Cholestyramine

Product NDC
27241-134
11-digit product format
272410134
Labeler code
27241
Product ID
27241-134_52a1ce3a-88e1-4902-990d-c57cf9735e42
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cholestyramine
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA211119
Marketing category
ANDA
Marketing start
2020-04-06
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
A211119-001CHOLESTYRAMINECHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2020-04-06
A211119-002CHOLESTYRAMINECHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2020-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211119-001AB
A211119-002AB

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 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A211119-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2020-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07A211119-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2020-04-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211119-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2020-04-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211119-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2020-04-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211119-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2020-04-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211119-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2020-04-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A211119-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2020-04-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211119-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2020-04-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211119-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2020-04-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211119-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2020-04-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211119-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2020-04-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211119-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2020-04-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211119-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2020-04-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211119-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2020-04-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211119-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2020-04-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211119-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2020-04-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211119-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2020-04-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211119-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2020-04-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211119-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2020-04-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211119-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2020-04-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211119-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2020-04-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A211119-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2020-04-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211119-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2020-04-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211119-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2020-04-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211119-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2020-04-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211119-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2020-04-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211119-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2020-04-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211119-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2020-04-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211119-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2020-04-068072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211119-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2020-04-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211119-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2020-04-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211119-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2020-04-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211119-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2020-04-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211119-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2020-04-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211119-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2020-04-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211119-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2020-04-064b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211119-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2020-04-06bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A211119-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2020-04-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211119-001CHOLESTYRAMINEEQ 4GM RESIN/PACKETPOWDER / ORALAB2020-04-06782e0a99824c…
2021-12-28 21:50 UTC2021-12A211119-002CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2020-04-06782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A211119-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211119-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A211119-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211119-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211119-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211119-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211119-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211119-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211119-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211119-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211119-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211119-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211119-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211119-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211119-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211119-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211119-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211119-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211119-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A211119-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A211119-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A211119-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211119-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A211119-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211119-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A211119-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211119-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A211119-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A211119-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A211119-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211119-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A211119-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A211119-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A211119-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A211119-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A211119-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A211119-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A211119-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A211119-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A211119-002AB1782e0a99824c…

Additional Listing Data#

Finished product
Yes
Brand name base
Cholestyramine
Listing expiration
2026-12-31

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
a0b64dfe-49bc-45d7-9281-9e9d6e296c40Available 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
27241-134-21Cholestyramine9 g in 1 PACKETPOWDER, FOR SUSPENSION96
27241-134-36Cholestyramine60 in 1 CARTONPOWDER, FOR SUSPENSION606
27241-134-51Cholestyramine378 g in 1 BOTTLEPOWDER, FOR SUSPENSION3786

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-134-51GM - Gram27241-134c37cb1c5-ca8e-4bb1-a559-607fb04e7f3f12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-134CHOLESTYRAMINE POWDER, FOR SUSPENSION [AJANTA PHARMA USA INC.]4Current NDC, Legacy NDC, 3 package rows20211124_a0b64dfe-49bc-45d7-9281-9e9d6e296c40.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CholestyramineCHOLESTYRAMINEAjanta Pharma USA Inc.a0b64dfe-49bc-45d7-9281-9e9d6e296c402025-10-08Adverse reactionsExact identifier
application applno (ANDA): 211119
application number: ANDA211119
ndc (product): 27241-134

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848943cholestyramine resin 4 GM Powder for Oral SuspensionPSNa0b64dfe-49bc-45d7-9281-9e9d6e296c406
848943cholestyramine resin 4000 MG Powder for Oral SuspensionSCDa0b64dfe-49bc-45d7-9281-9e9d6e296c406
848943cholestyramine resin 4 GM per 9 GM Powder for Oral SuspensionSYa0b64dfe-49bc-45d7-9281-9e9d6e296c406
848943cholestyramine resin 4 GM Powder for Oral SuspensionSYa0b64dfe-49bc-45d7-9281-9e9d6e296c406

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27241-134-21272410134219 g in 1 PACKET9 gHistorical
27241-134-362724101343660 PACKET in 1 CARTON (27241-134-36) / 9 g in 1 PACKET (27241-134-21) 60 packet2020-04-060000-00-00NoNoCurrent
27241-134-5127241013451378 g in 1 BOTTLE (27241-134-51) 378 g2020-04-060000-00-00NoNoCurrent