FDA.reportPublic FDA data

Cholestyramine

Product NDC
68094-906
11-digit product format
680940906
Labeler code
68094
Product ID
68094-906_37093f43-91d8-424c-98d9-8a07334454ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cholestyramine
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Precision Dose, Inc.
Application
ANDA209599
Marketing category
ANDA
Marketing start
2023-12-15
Substance
CHOLESTYRAMINE
Active strength
4 g/4.8g
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/4.8g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4B33BGI082
Rxcui1801279

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bafdcfac-da3a-43c4-81f4-296b60084636Product name620250623
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68094-906-10Cholestyramine201.6 g in 1 CANPOWDER, FOR SUSPENSION201.61
68094-906-20Cholestyramine60 in 1 CARTONPOWDER, FOR SUSPENSION601
68094-906-20Cholestyramine4.8 g in 1 POUCHPOWDER, FOR SUSPENSION4.81

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-906CHOLESTYRAMINE POWDER, FOR SUSPENSION [PRECISION DOSE, INC.]1Current NDC, 3 package rows20231222_129fa522-b66b-4bb1-9ac6-74f98d93a86f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1801279cholestyramine Sugar-Free 4 GM Powder for Oral SuspensionPSN129fa522-b66b-4bb1-9ac6-74f98d93a86f1
1801279Sugar-Free cholestyramine resin 4000 MG Powder for Oral SuspensionSCD129fa522-b66b-4bb1-9ac6-74f98d93a86f1
1801279cholestyramine Sugar-Free 4 GM Powder for Oral SuspensionSY129fa522-b66b-4bb1-9ac6-74f98d93a86f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68094-906-1068094090610201.6 g in 1 CAN (68094-906-10) 201.6 g2023-12-15NoNoCurrent
68094-906-206809409062060 POUCH in 1 CARTON (68094-906-20) / 4.8 g in 1 POUCH60 pouch2023-12-15NoNoCurrent