CHOLESTYRAMINE

Product NDC
70771-1105
11-digit product format
707711105
Labeler code
70771
Product ID
70771-1105_8ad37d77-a00f-433b-a21a-4b063f4b887d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHOLESTYRAMINE
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA202901
Marketing category
ANDA
Marketing start
2018-08-01
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
2027-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202901-001CHOLESTYRAMINECHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202901-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-023f01610625f2…
2019-09-15 20:21 UTC2019-09A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-02e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202901-001CHOLESTYRAMINEEQ 4GM RESIN/SCOOPFULPOWDER / ORALAB2018-07-02cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A202901-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202901-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202901-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202901-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202901-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202901-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202901-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202901-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202901-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202901-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202901-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202901-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202901-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202901-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A202901-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A202901-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A202901-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A202901-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A202901-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A202901-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A202901-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A202901-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A202901-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A202901-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A202901-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A202901-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A202901-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A202901-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A202901-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A202901-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A202901-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A202901-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A202901-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A202901-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A202901-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A202901-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A202901-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A202901-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A202901-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A202901-001AB1cb3db0bc1861…

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
a86715e3-741f-47c6-9682-1413f0f8ff0cAvailable 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
70771-1105-1CHOLESTYRAMINE378 g in 1 CANPOWDER, FOR SUSPENSION3785
70771-1105-2CHOLESTYRAMINE60 in 1 CARTONPOWDER, FOR SUSPENSION605
70771-1105-2CHOLESTYRAMINE9 g in 1 POUCHPOWDER, FOR SUSPENSION95

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1105CHOLESTYRAMINE POWDER, FOR SUSPENSION [ZYDUS LIFESCIENCES LIMITED]4Current NDC, Legacy NDC, 3 package rows20240110_a86715e3-741f-47c6-9682-1413f0f8ff0c.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 Pharmaceuticals (USA) Inc.acc48703-c15b-4275-aa75-749f1c07dcbb2026-04-28Adverse reactionsExact identifier
application applno (ANDA): 202901
application number: ANDA202901
CHOLESTYRAMINECHOLESTYRAMINEZydus Lifesciences Limiteda86715e3-741f-47c6-9682-1413f0f8ff0c2026-04-28Adverse reactionsExact identifier
application applno (ANDA): 202901
application number: ANDA202901
ndc (product): 70771-1105

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848943cholestyramine resin 4 GM Powder for Oral SuspensionPSNa86715e3-741f-47c6-9682-1413f0f8ff0c5
848943cholestyramine resin 4000 MG Powder for Oral SuspensionSCDa86715e3-741f-47c6-9682-1413f0f8ff0c5
848943cholestyramine resin 4 GM per 9 GM Powder for Oral SuspensionSYa86715e3-741f-47c6-9682-1413f0f8ff0c5
848943cholestyramine resin 4 GM Powder for Oral SuspensionSYa86715e3-741f-47c6-9682-1413f0f8ff0c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70771-1105-170771110501378 g in 1 CAN (70771-1105-1) 378 g2018-08-010000-00-00NoNoCurrent
70771-1105-27077111050260 POUCH in 1 CARTON (70771-1105-2) / 9 g in 1 POUCH60 pouch2018-08-010000-00-00NoNoCurrent