FDA.reportPublic FDA data

CHOLESTYRAMINE

Product NDC
42806-266
11-digit product format
428060266
Labeler code
42806
Product ID
42806-266_6001add4-b16b-4336-b53f-4d52ea8fd899
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cholestyramine
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
EPIC PHARMA, LLC
Application
ANDA074557
Marketing category
ANDA
Marketing start
2021-12-15
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

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
42806-266-95CHOLESTYRAMINE60 in 1 CARTONPOWDER, FOR SUSPENSION608
42806-266-98CHOLESTYRAMINE9 g in 1 POUCHPOWDER, FOR SUSPENSION98

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-266-95EA - Each42806-26686c8da68-056c-4bb7-82a5-ee8e5079ae0012022-01-06
42806-266-98EA - Each42806-266fbdd3aa8-f415-401c-bdfd-f955d56983d212024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-266CHOLESTYRAMINE POWDER, FOR SUSPENSION [EPIC PHARMA, LLC]7Current NDC, Legacy NDC, 2 package rows20240726_d931e372-2477-4554-912e-9d4d7d538ce2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848943cholestyramine resin 4 GM Powder for Oral SuspensionPSNd931e372-2477-4554-912e-9d4d7d538ce28
848943cholestyramine resin 4000 MG Powder for Oral SuspensionSCDd931e372-2477-4554-912e-9d4d7d538ce28
848943cholestyramine resin 4 GM per 9 GM Powder for Oral SuspensionSYd931e372-2477-4554-912e-9d4d7d538ce28
848943cholestyramine resin 4 GM Powder for Oral SuspensionSYd931e372-2477-4554-912e-9d4d7d538ce28

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-266-954280602669560 POUCH in 1 CARTON (42806-266-95) / 9 g in 1 POUCH (42806-266-98) 60 pouch2021-12-150000-00-00NoNoCurrent
42806-266-98428060266989 g in 1 POUCH9 gHistorical