FDA.reportPublic FDA data

CHOLESTYRAMINE

Product NDC
42806-267
11-digit product format
428060267
Labeler code
42806
Product ID
42806-267_f8db9100-22d4-4828-9e5b-b6e4e639de08
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
42806-267-93CHOLESTYRAMINE378 g in 1 JARPOWDER, FOR SUSPENSION3788
42806-267-97CHOLESTYRAMINE378 g in 1 CANPOWDER, FOR SUSPENSION3788

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-267-93GM - Gram42806-2670fc49fef-e30f-4860-bf5e-3614a15081b912024-04-05
42806-267-97GM - Gram42806-26765aeba1d-7c64-4258-9933-3b1849b6ff3e12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-267CHOLESTYRAMINE POWDER, FOR SUSPENSION [EPIC PHARMA, LLC]7Current NDC, Legacy NDC, 2 package rows20240730_c65e556a-3b6a-4466-a7ce-5b24103ed8ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848943cholestyramine resin 4 GM Powder for Oral SuspensionPSNc65e556a-3b6a-4466-a7ce-5b24103ed8ad8
848943cholestyramine resin 4000 MG Powder for Oral SuspensionSCDc65e556a-3b6a-4466-a7ce-5b24103ed8ad8
848943cholestyramine resin 4 GM per 9 GM Powder for Oral SuspensionSYc65e556a-3b6a-4466-a7ce-5b24103ed8ad8
848943cholestyramine resin 4 GM Powder for Oral SuspensionSYc65e556a-3b6a-4466-a7ce-5b24103ed8ad8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-267-9342806026793378 g in 1 JAR (42806-267-93) 378 g2023-09-29NoNoCurrent
42806-267-9742806026797378 g in 1 CAN (42806-267-97) 378 g2021-12-150000-00-00NoNoCurrent