FDA.reportPublic FDA data

CHOLESTYRAMINE LIGHT

Product NDC
42806-271
11-digit product format
428060271
Labeler code
42806
Product ID
42806-271_f21139d8-d54b-4fbc-add3-aa4bcefb4e2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cholestyramine light
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
EPIC PHARMA, LLC
Application
ANDA074558
Marketing category
ANDA
Marketing start
2021-12-15
Substance
CHOLESTYRAMINE
Active strength
4 g/5.7g
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 LIGHT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHOLESTYRAMINE4 g/5.7g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4B33BGI082
Rxcui1801279

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
42806-271-93CHOLESTYRAMINE LIGHT239.6 g in 1 JARPOWDER, FOR SUSPENSION239.68
42806-271-97CHOLESTYRAMINE LIGHT239.6 g in 1 CANPOWDER, FOR SUSPENSION239.68

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-271-93GM - Gram42806-271b4fa8740-33f5-4299-9596-74ace3aafd0f12024-03-12
42806-271-97GM - Gram42806-27116607268-a9e3-44b6-b555-ad8b76cdd94612022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-271CHOLESTYRAMINE LIGHT POWDER, FOR SUSPENSION [EPIC PHARMA, LLC]7Current NDC, Legacy NDC, 2 package rows20240726_f8740b85-75f9-4e00-a8d3-7175298f1724.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1801279cholestyramine Sugar-Free 4 GM Powder for Oral SuspensionPSNf8740b85-75f9-4e00-a8d3-7175298f17248
1801279Sugar-Free cholestyramine resin 4000 MG Powder for Oral SuspensionSCDf8740b85-75f9-4e00-a8d3-7175298f17248
1801279cholestyramine Sugar-Free 4 GM Powder for Oral SuspensionSYf8740b85-75f9-4e00-a8d3-7175298f17248

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-271-9342806027193239.6 g in 1 JAR (42806-271-93) 239.6 g2023-09-29NoNoHistorical
42806-271-9742806027197239.6 g in 1 CAN (42806-271-97) 239.6 g2021-12-150000-00-00NoNoCurrent