CHOLESTYRAMINE

Product NDC
68382-528
11-digit product format
683820528
Labeler code
68382
Product ID
68382-528_05ac7932-41c3-4434-8655-d47bfa6db8b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHOLESTYRAMINE
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA202901
Marketing category
ANDA
Marketing start
2018-08-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CHOLESTYRAMINE
Listing expiration
2027-12-31

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
68382-528-42CHOLESTYRAMINE378 g in 1 CANPOWDER, FOR SUSPENSION3786
68382-528-60CHOLESTYRAMINE60 in 1 CARTONPOWDER, FOR SUSPENSION606
68382-528-60CHOLESTYRAMINE9 g in 1 POUCHPOWDER, FOR SUSPENSION96

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-528CHOLESTYRAMINE POWDER, FOR SUSPENSION [ZYDUS PHARMACEUTICALS (USA) INC.]5Current NDC, Legacy NDC, 3 package rows20240110_acc48703-c15b-4275-aa75-749f1c07dcbb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848943cholestyramine resin 4 GM Powder for Oral SuspensionPSNacc48703-c15b-4275-aa75-749f1c07dcbb6
848943cholestyramine resin 4000 MG Powder for Oral SuspensionSCDacc48703-c15b-4275-aa75-749f1c07dcbb6
848943cholestyramine resin 4 GM per 9 GM Powder for Oral SuspensionSYacc48703-c15b-4275-aa75-749f1c07dcbb6
848943cholestyramine resin 4 GM Powder for Oral SuspensionSYacc48703-c15b-4275-aa75-749f1c07dcbb6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-528-4268382052842378 g in 1 CAN (68382-528-42) 378 g2018-08-010000-00-00NoNoCurrent
68382-528-606838205286060 POUCH in 1 CARTON (68382-528-60) / 9 g in 1 POUCH60 pouch2018-08-010000-00-00NoNoCurrent