FDA.reportPublic FDA data

CHOLESTYRAMINE LIGHT

Product NDC
24658-270
11-digit product format
246580270
Labeler code
24658
Product ID
24658-270_fd2993a6-d5ce-4853-8912-e7b5e6de5585
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cholestyramine light
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS
Application
ANDA074558
Marketing category
ANDA
Marketing start
2023-03-14
Substance
CHOLESTYRAMINE
Active strength
4 g/5.7g
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 LIGHT
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHOLESTYRAMINE4 g/5.7g

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24658-270-95CHOLESTYRAMINE LIGHT5.7 g in 1 POUCHPOWDER, FOR SUSPENSION5.74
24658-270-95CHOLESTYRAMINE LIGHT60 in 1 CARTONPOWDER, FOR SUSPENSION604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24658-270-95EA - Each24658-270041ef428-6b5e-4ca4-8efa-88526a84953012023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24658-270CHOLESTYRAMINE LIGHT POWDER, FOR SUSPENSION [PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS]3Current NDC, 2 package rows20240726_31655681-125c-4eaa-959b-8f434bb43590.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1801279cholestyramine Sugar-Free 4 GM Powder for Oral SuspensionPSN31655681-125c-4eaa-959b-8f434bb435904
1801279Sugar-Free cholestyramine resin 4000 MG Powder for Oral SuspensionSCD31655681-125c-4eaa-959b-8f434bb435904
1801279cholestyramine Sugar-Free 4 GM Powder for Oral SuspensionSY31655681-125c-4eaa-959b-8f434bb435904

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
24658-270-952465802709560 POUCH in 1 CARTON (24658-270-95) / 5.7 g in 1 POUCH60 pouch2023-03-14NoNoCurrent