FDA.reportPublic FDA data

Choleystyramine Light

Product NDC
63629-9466
11-digit product format
636299466
Labeler code
63629
Product ID
63629-9466_9cf4eca0-aad5-4c52-98c4-1e542e712353
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Choleystyramine Light
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211799
Marketing category
ANDA
Marketing start
2021-10-20
Substance
CHOLESTYRAMINE
Active strength
4 g/5.718g
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
Choleystyramine Light
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHOLESTYRAMINE4 g/5.718g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4B33BGI082
Rxcui1801279

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
63629-9466-1Choleystyramine Light5.718 g in 1 POUCHPOWDER, FOR SUSPENSION5.718101
63629-9466-1Choleystyramine Light60 in 1 CARTONPOWDER, FOR SUSPENSION60101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9466-1EA - Each63629-94661369b588-b282-4b83-9176-f6a573ae8d3712023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9466CHOLEYSTYRAMINE LIGHT POWDER, FOR SUSPENSION [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 2 package rows20240113_9f6f0e30-7eba-45eb-927a-f7150b043d43.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1801279cholestyramine Sugar-Free 4 GM Powder for Oral SuspensionPSN9f6f0e30-7eba-45eb-927a-f7150b043d43101
1801279Sugar-Free cholestyramine resin 4000 MG Powder for Oral SuspensionSCD9f6f0e30-7eba-45eb-927a-f7150b043d43101
1801279cholestyramine Sugar-Free 4 GM Powder for Oral SuspensionSY9f6f0e30-7eba-45eb-927a-f7150b043d43101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9466-16362994660160 POUCH in 1 CARTON (63629-9466-1) / 5.718 g in 1 POUCH60 pouch2022-11-280000-00-00NoNoCurrent