FDA.reportPublic FDA data

Cholestyramine

Product NDC
51224-011
11-digit product format
512240011
Labeler code
51224
Product ID
51224-011_94d7bc24-2f81-463b-b646-92fbf6641f71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Cholestyramine
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
TAGI Pharma, Inc.
Application
ANDA209597
Marketing category
ANDA
Marketing start
2021-03-10
Marketing end
2026-11-30
Substance
CHOLESTYRAMINE
Active strength
4 g/8.3g
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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHOLESTYRAMINE4 g/8.3g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4B33BGI082
Rxcui848943

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bafdcfac-da3a-43c4-81f4-296b60084636Product name620250623
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51224-011-10Cholestyramine348.6 g in 1 CANPOWDER, FOR SUSPENSION348.64
51224-011-20Cholestyramine60 in 1 CARTONPOWDER, FOR SUSPENSION604
51224-011-20Cholestyramine8.3 g in 1 POUCHPOWDER, FOR SUSPENSION8.34

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51224-011-10GM - Gram51224-01195a36104-250c-413d-9100-d927e1bf38d712021-11-09
51224-011-20EA - Each51224-0115394f11f-21f9-4a0b-a8f0-d50bc4c66dcd12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51224-011CHOLESTYRAMINE POWDER, FOR SUSPENSION [TAGI PHARMA, INC.]4Current NDC, Legacy NDC, 3 package rows20250424_06261db5-1435-4b91-8b54-71bfcfb1368c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848943cholestyramine resin 4 GM Powder for Oral SuspensionPSN06261db5-1435-4b91-8b54-71bfcfb1368c4
848943cholestyramine resin 4000 MG Powder for Oral SuspensionSCD06261db5-1435-4b91-8b54-71bfcfb1368c4
848943cholestyramine resin 4 GM per 9 GM Powder for Oral SuspensionSY06261db5-1435-4b91-8b54-71bfcfb1368c4
848943cholestyramine resin 4 GM Powder for Oral SuspensionSY06261db5-1435-4b91-8b54-71bfcfb1368c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51224-011-1051224001110348.6 g in 1 CAN (51224-011-10) 348.6 g2021-03-102026-11-30NoNoCurrent
51224-011-205122400112060 POUCH in 1 CARTON (51224-011-20) / 8.3 g in 1 POUCH60 pouch2021-03-102026-11-30NoNoCurrent