FDA.reportPublic FDA data

Cholestyramine

Product NDC
33342-293
11-digit product format
333420293
Labeler code
33342
Product ID
33342-293_96fd22fa-700e-4d41-b433-617dc457c2b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cholestyramine
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA207294
Marketing category
ANDA
Marketing start
2024-11-21
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
33342-293-70Cholestyramine60 in 1 CARTONPOWDER, FOR SUSPENSION604
33342-293-71Cholestyramine378 g in 1 JARPOWDER, FOR SUSPENSION3784
33342-293-75Cholestyramine9 g in 1 POUCHPOWDER, FOR SUSPENSION94

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-293-70EA - Each33342-29366ee6974-5a88-4d5d-94a3-f4e4f80dcea712026-04-20
33342-293-71GM - Gram33342-2938c1d69e4-b953-45ac-971c-580cbeb9a4e212026-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-293CHOLESTYRAMINE POWDER, FOR SUSPENSION [MACLEODS PHARMACEUTICALS LIMITED]1Current NDC, 3 package rows20250131_8cbb1ed2-66cc-485d-a4b1-920f89fb6b3b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848943cholestyramine resin 4 GM Powder for Oral SuspensionPSN8cbb1ed2-66cc-485d-a4b1-920f89fb6b3b4
848943cholestyramine resin 4000 MG Powder for Oral SuspensionSCD8cbb1ed2-66cc-485d-a4b1-920f89fb6b3b4
848943cholestyramine resin 4 GM per 9 GM Powder for Oral SuspensionSY8cbb1ed2-66cc-485d-a4b1-920f89fb6b3b4
848943cholestyramine resin 4 GM Powder for Oral SuspensionSY8cbb1ed2-66cc-485d-a4b1-920f89fb6b3b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-293-703334202937060 POUCH in 1 CARTON (33342-293-70) / 9 g in 1 POUCH (33342-293-75) 60 pouch2024-11-21NoNoHistorical
33342-293-7133342029371378 g in 1 JAR (33342-293-71) 378 g2024-11-21NoNoHistorical
33342-293-75333420293759 g in 1 POUCH9 gHistorical