FDA.reportPublic FDA data

CHOLESTYRAMINE

Product NDC
68382-529
11-digit product format
683820529
Labeler code
68382
Product ID
68382-529_11d83a73-e97b-466d-9af9-2882e7a094b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHOLESTYRAMINE
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA202902
Marketing category
ANDA
Marketing start
2017-06-08
Substance
CHOLESTYRAMINE
Active strength
4 g/5.5g
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHOLESTYRAMINE4 g/5.5g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4B33BGI082
Rxcui1801279

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-529-42CHOLESTYRAMINE231 g in 1 CONTAINERPOWDER, FOR SUSPENSION2314
68382-529-60CHOLESTYRAMINE60 in 1 CARTONPOWDER, FOR SUSPENSION604
68382-529-60CHOLESTYRAMINE5.5 g in 1 POUCHPOWDER, FOR SUSPENSION5.54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-529-42GM - Gram68382-529e2dccb4e-dfff-4552-b121-15f799e350d412018-02-20
68382-529-60EA - Each68382-5293355adc7-6e9a-4369-a9c9-fb54a6962dee12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-529CHOLESTYRAMINE POWDER, FOR SUSPENSION [ZYDUS PHARMACEUTICALS (USA) INC.]4Current NDC, Legacy NDC, 3 package rows20240126_2dcf7652-0c3e-4bc3-abfd-20a5b3d2a4f4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1801279cholestyramine Sugar-Free 4 GM Powder for Oral SuspensionPSN2dcf7652-0c3e-4bc3-abfd-20a5b3d2a4f44
1801279Sugar-Free cholestyramine resin 4000 MG Powder for Oral SuspensionSCD2dcf7652-0c3e-4bc3-abfd-20a5b3d2a4f44
1801279cholestyramine Sugar-Free 4 GM Powder for Oral SuspensionSY2dcf7652-0c3e-4bc3-abfd-20a5b3d2a4f44
1801279cholestyramine Sugar-Free 4 GM Powder for Oral SuspensionPSNe7443ed0-6fbc-47bd-898d-0d990546536c1
1801279Sugar-Free cholestyramine resin 4000 MG Powder for Oral SuspensionSCDe7443ed0-6fbc-47bd-898d-0d990546536c1
1801279cholestyramine Sugar-Free 4 GM Powder for Oral SuspensionSYe7443ed0-6fbc-47bd-898d-0d990546536c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-529-4268382052942231 g in 1 CONTAINER (68382-529-42) 231 g2017-06-080000-00-00NoNoCurrent
68382-529-606838205296060 POUCH in 1 CARTON (68382-529-60) / 5.5 g in 1 POUCH60 pouch2017-06-080000-00-00NoNoCurrent