FDA.reportPublic FDA data

Cholestyramine

Product NDC
68094-806
11-digit product format
680940806
Labeler code
68094
Product ID
68094-806_7c0786fa-dc69-4bc6-aa53-664938642855
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cholestyramine
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Precision Dose, Inc.
Application
ANDA209597
Marketing category
ANDA
Marketing start
2024-04-25
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
68094-806-10Cholestyramine348.6 g in 1 CANPOWDER, FOR SUSPENSION348.62
68094-806-20Cholestyramine60 in 1 CARTONPOWDER, FOR SUSPENSION602
68094-806-20Cholestyramine9 g in 1 POUCHPOWDER, FOR SUSPENSION92

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-806-10GM - Gram68094-8069558a4ec-1c82-48cd-800f-4b8f2a84b13412024-07-12
68094-806-20EA - Each68094-8069c1a0f0e-ac5f-45a5-8128-f3e4a939f12612024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-806CHOLESTYRAMINE POWDER, FOR SUSPENSION [PRECISION DOSE, INC.]2Current NDC, 3 package rows20250316_8c7fc9c8-318c-42de-a736-c439047d8af8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848943cholestyramine resin 4 GM Powder for Oral SuspensionPSN8c7fc9c8-318c-42de-a736-c439047d8af82
848943cholestyramine resin 4000 MG Powder for Oral SuspensionSCD8c7fc9c8-318c-42de-a736-c439047d8af82
848943cholestyramine resin 4 GM per 9 GM Powder for Oral SuspensionSY8c7fc9c8-318c-42de-a736-c439047d8af82
848943cholestyramine resin 4 GM Powder for Oral SuspensionSY8c7fc9c8-318c-42de-a736-c439047d8af82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68094-806-1068094080610348.6 g in 1 CAN (68094-806-10) 348.6 g2024-04-25NoNoHistorical
68094-806-206809408062060 POUCH in 1 CARTON (68094-806-20) / 9 g in 1 POUCH60 pouch2024-04-25NoNoHistorical