FDA.reportPublic FDA data

cholestyramine powder for suspension

Product NDC
67877-298
11-digit product format
678770298
Labeler code
67877
Product ID
67877-298_2871b3b9-3aa9-44b6-99ce-eab69a607bcb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cholestyramine powder for suspension
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA211856
Marketing category
ANDA
Marketing start
2021-10-20
Substance
CHOLESTYRAMINE
Active strength
4 g/8.78g
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 powder for suspension
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHOLESTYRAMINE4 g/8.78g

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-298-09cholestyramine powder for suspension8.780 g in 1 POUCHPOWDER, FOR SUSPENSION8.7805
67877-298-37cholestyramine powder for suspension368.760 g in 1 JARPOWDER, FOR SUSPENSION368.7605
67877-298-60cholestyramine powder for suspension60 in 1 CARTONPOWDER, FOR SUSPENSION605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-298-09EA - Each67877-298ebcb4068-d230-41ca-8385-2a1dcb9644a312021-12-08
67877-298-37GM - Gram67877-29898edd559-49e1-4863-80fe-e6f0b54f1a1512021-12-08
67877-298-60EA - Each67877-29845529c7a-54c8-4e12-9127-2c1a67b8d73512021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-298CHOLESTYRAMINE POWDER FOR SUSPENSION POWDER, FOR SUSPENSION [ASCEND LABORATORIES, LLC]5Current NDC, Legacy NDC, 3 package rows20220708_430ac07e-8524-4dec-a599-b7ebc56d9563.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
848943cholestyramine resin 4 GM Powder for Oral SuspensionPSN5238dc45-a2b7-4208-b1a7-cc695b6cd1f0108
848943cholestyramine resin 4000 MG Powder for Oral SuspensionSCD5238dc45-a2b7-4208-b1a7-cc695b6cd1f0108
848943cholestyramine resin 4 GM per 9 GM Powder for Oral SuspensionSY5238dc45-a2b7-4208-b1a7-cc695b6cd1f0108
848943cholestyramine resin 4 GM Powder for Oral SuspensionSY5238dc45-a2b7-4208-b1a7-cc695b6cd1f0108
848943cholestyramine resin 4 GM Powder for Oral SuspensionPSN31d04422-f159-42ba-8eb5-b0ec1dbc52f9101
848943cholestyramine resin 4 GM Powder for Oral SuspensionPSN408ad775-9a1b-43cc-b122-226ade73e0c2101
848943cholestyramine resin 4000 MG Powder for Oral SuspensionSCD31d04422-f159-42ba-8eb5-b0ec1dbc52f9101
848943cholestyramine resin 4000 MG Powder for Oral SuspensionSCD408ad775-9a1b-43cc-b122-226ade73e0c2101
848943cholestyramine resin 4 GM per 9 GM Powder for Oral SuspensionSY31d04422-f159-42ba-8eb5-b0ec1dbc52f9101
848943cholestyramine resin 4 GM per 9 GM Powder for Oral SuspensionSY408ad775-9a1b-43cc-b122-226ade73e0c2101
848943cholestyramine resin 4 GM Powder for Oral SuspensionSY31d04422-f159-42ba-8eb5-b0ec1dbc52f9101
848943cholestyramine resin 4 GM Powder for Oral SuspensionSY408ad775-9a1b-43cc-b122-226ade73e0c2101
848943cholestyramine resin 4 GM Powder for Oral SuspensionPSN430ac07e-8524-4dec-a599-b7ebc56d95635
848943cholestyramine resin 4000 MG Powder for Oral SuspensionSCD430ac07e-8524-4dec-a599-b7ebc56d95635
848943cholestyramine resin 4 GM per 9 GM Powder for Oral SuspensionSY430ac07e-8524-4dec-a599-b7ebc56d95635
848943cholestyramine resin 4 GM Powder for Oral SuspensionSY430ac07e-8524-4dec-a599-b7ebc56d95635

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-298-09678770298098.780 g in 1 POUCH8.780 gHistorical
67877-298-3767877029837368.76 g in 1 JAR (67877-298-37) 368.76 g2021-10-200000-00-00NoNoCurrent
67877-298-606787702986060 POUCH in 1 CARTON (67877-298-60) / 8.78 g in 1 POUCH (67877-298-09) 60 pouch2021-10-200000-00-00NoNoCurrent