FDA.reportPublic FDA data

Cholestyramine Light

Product NDC
51224-009
11-digit product format
512240009
Labeler code
51224
Product ID
51224-009_fb8b0e9c-1750-4016-95c7-d7a49e09d463
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cholestyramine
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
TAGI Pharma, Inc.
Application
ANDA209599
Marketing category
ANDA
Marketing start
2020-11-12
Marketing end
2027-01-31
Substance
CHOLESTYRAMINE
Active strength
4 g/4.8g
Pharmacologic classes
Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cholestyramine Light

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51224-009-10Cholestyramine Light201.6 g in 1 CANPOWDER, FOR SUSPENSION201.64
51224-009-20Cholestyramine Light60 in 1 CARTONPOWDER, FOR SUSPENSION604
51224-009-20Cholestyramine Light4.8 g in 1 POUCHPOWDER, FOR SUSPENSION4.84

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51224-009-10GM - Gram51224-0099deb3385-4a6f-40d6-82b9-79c6082f9d6412021-11-09
51224-009-20EA - Each51224-009560ca710-c9fd-4c58-84c0-dde26b5da93712021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51224-009CHOLESTYRAMINE LIGHT (CHOLESTYRAMINE) POWDER, FOR SUSPENSION [TAGI PHARMA, INC.]4Current NDC, Legacy NDC, 3 package rows20250424_eb85a2c8-cdc3-48bb-844d-e220ae3701a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1801279cholestyramine Sugar-Free 4 GM Powder for Oral SuspensionPSNeb85a2c8-cdc3-48bb-844d-e220ae3701a04
1801279Sugar-Free cholestyramine resin 4000 MG Powder for Oral SuspensionSCDeb85a2c8-cdc3-48bb-844d-e220ae3701a04
1801279cholestyramine Sugar-Free 4 GM Powder for Oral SuspensionSYeb85a2c8-cdc3-48bb-844d-e220ae3701a04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51224-009-1051224000910201.6 g in 1 CAN (51224-009-10) 201.6 g2020-11-122027-01-31NoNoCurrent
51224-009-205122400092060 POUCH in 1 CARTON (51224-009-20) > 4.8 g in 1 POUCH60 pouch2020-11-120000-00-00NoNoCurrent