FDA.reportPublic FDA data

CHOLESTYRAMINE

Product NDC
24658-266
11-digit product format
246580266
Labeler code
24658
Product ID
24658-266_7c3a3854-b045-4b67-ba97-eb980be64817
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cholestyramine
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS
Application
ANDA074557
Marketing category
ANDA
Marketing start
2023-03-14
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

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 Identifiers#

Field, Values table
FieldValues
Unii4B33BGI082
Rxcui848943

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
24658-266-93CHOLESTYRAMINE378 g in 1 JARPOWDER, FOR SUSPENSION3784
24658-266-95CHOLESTYRAMINE60 in 1 CARTONPOWDER, FOR SUSPENSION604
24658-266-95CHOLESTYRAMINE9 g in 1 POUCHPOWDER, FOR SUSPENSION94
24658-266-97CHOLESTYRAMINE378 g in 1 CANPOWDER, FOR SUSPENSION3784

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24658-266CHOLESTYRAMINE POWDER, FOR SUSPENSION [PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS]3Current NDC, 4 package rows20240726_d82647da-465b-4e2e-8cf8-72d50f047b3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848943cholestyramine resin 4 GM Powder for Oral SuspensionPSNd82647da-465b-4e2e-8cf8-72d50f047b3e4
848943cholestyramine resin 4000 MG Powder for Oral SuspensionSCDd82647da-465b-4e2e-8cf8-72d50f047b3e4
848943cholestyramine resin 4 GM per 9 GM Powder for Oral SuspensionSYd82647da-465b-4e2e-8cf8-72d50f047b3e4
848943cholestyramine resin 4 GM Powder for Oral SuspensionSYd82647da-465b-4e2e-8cf8-72d50f047b3e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
24658-266-9324658026693378 g in 1 JAR (24658-266-93) 378 g2024-04-29NoNoCurrent
24658-266-952465802669560 POUCH in 1 CARTON (24658-266-95) / 9 g in 1 POUCH60 pouch2023-03-14NoNoCurrent
24658-266-9724658026697378 g in 1 CAN (24658-266-97) 378 g2023-03-14NoNoCurrent