cholestyramine powder for suspension

Product NDC
63629-9196
11-digit product format
636299196
Labeler code
63629
Product ID
63629-9196_d4518736-904a-41ee-92a2-2d9853473af6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cholestyramine powder for suspension
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211856
Marketing category
ANDA
Marketing start
2021-10-20
Substance
CHOLESTYRAMINE
Active strength
4 g/8.78g
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 powder for suspension
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHOLESTYRAMINE4 g/8.78g

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
63629-9196-1cholestyramine powder for suspension368.760 g in 1 JARPOWDER, FOR SUSPENSION368.760108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9196CHOLESTYRAMINE POWDER FOR SUSPENSION POWDER, FOR SUSPENSION [BRYANT RANCH PREPACK]108Current NDC, Legacy NDC, 1 package rows20241228_5238dc45-a2b7-4208-b1a7-cc695b6cd1f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848943cholestyramine resin 4 GM Powder for Oral SuspensionPSN5238dc45-a2b7-4208-b1a7-cc695b6cd1f0108
848943cholestyramine resin 4000 MG Powder for Oral SuspensionSCD5238dc45-a2b7-4208-b1a7-cc695b6cd1f0108
848943cholestyramine resin 4 GM per 9 GM Powder for Oral SuspensionSY5238dc45-a2b7-4208-b1a7-cc695b6cd1f0108
848943cholestyramine resin 4 GM Powder for Oral SuspensionSY5238dc45-a2b7-4208-b1a7-cc695b6cd1f0108

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9196-163629919601368.76 g in 1 JAR (63629-9196-1) 368.76 g2022-08-250000-00-00NoNoCurrent