FDA.reportPublic FDA data

Cholestyramine

Product NDC
33342-319
11-digit product format
333420319
Labeler code
33342
Product ID
33342-319_c41529f1-16d2-4ca3-91eb-f809571f5ae3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cholestyramine
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA209109
Marketing category
ANDA
Marketing start
2024-11-21
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
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
33342-319-01Cholestyramine5.7 g in 1 POUCHPOWDER, FOR SUSPENSION5.71
33342-319-70Cholestyramine60 in 1 CARTONPOWDER, FOR SUSPENSION601
33342-319-72Cholestyramine42 in 1 CARTONPOWDER, FOR SUSPENSION421
33342-319-83Cholestyramine239.4 g in 1 JARPOWDER, FOR SUSPENSION239.41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-319CHOLESTYRAMINE POWDER, FOR SUSPENSION [MACLEODS PHARMACEUTICALS LIMITED]1Current NDC, 4 package rows20250131_c41529f1-16d2-4ca3-91eb-f809571f5ae3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1801279cholestyramine Sugar-Free 4 GM Powder for Oral SuspensionPSNc41529f1-16d2-4ca3-91eb-f809571f5ae31
1801279Sugar-Free cholestyramine resin 4000 MG Powder for Oral SuspensionSCDc41529f1-16d2-4ca3-91eb-f809571f5ae31
1801279cholestyramine Sugar-Free 4 GM Powder for Oral SuspensionSYc41529f1-16d2-4ca3-91eb-f809571f5ae31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-319-01333420319015.7 g in 1 POUCH5.7 gHistorical
33342-319-703334203197060 POUCH in 1 CARTON (33342-319-70) / 5.7 g in 1 POUCH (33342-319-01) 60 pouch2024-11-21NoNoCurrent
33342-319-723334203197242 POUCH in 1 CARTON (33342-319-72) / 5.7 g in 1 POUCH (33342-319-01) 42 pouch2024-11-21NoNoCurrent
33342-319-8333342031983239.4 g in 1 JAR (33342-319-83) 239.4 g2024-11-21NoNoCurrent