FDA.reportPublic FDA data

Choleystyramine Light

Product NDC
67877-422
11-digit product format
678770422
Labeler code
67877
Product ID
67877-422_a07c3c73-7408-40a1-9c2d-36d47ade8b0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Choleystyramine Light
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA211799
Marketing category
ANDA
Marketing start
2021-10-20
Substance
CHOLESTYRAMINE
Active strength
4 g/5.718g
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
Choleystyramine Light
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHOLESTYRAMINE4 g/5.718g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4B33BGI082
Rxcui1801279

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bafdcfac-da3a-43c4-81f4-296b60084636Product name620250623
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-422-24Choleystyramine Light240.156 g in 1 JARPOWDER, FOR SUSPENSION240.1566
67877-422-57Choleystyramine Light5.718 g in 1 POUCHPOWDER, FOR SUSPENSION5.7186
67877-422-60Choleystyramine Light60 in 1 CARTONPOWDER, FOR SUSPENSION606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-422-24GM - Gram67877-422b17516b7-53a3-4a46-a1b0-8375d35cd67512023-02-06
67877-422-57EA - Each67877-4222355d176-2318-446e-822b-63fb55ff829e12022-09-12
67877-422-60EA - Each67877-42206c7dac3-700e-4c9f-9547-2668700fc30212022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-422CHOLEYSTYRAMINE LIGHT POWDER, FOR SUSPENSION [ASCEND LABORATORIES, LLC]6Current NDC, Legacy NDC, 3 package rows20220713_4c9d4561-d5b5-463b-ac57-1bc4d84d135d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1801279cholestyramine Sugar-Free 4 GM Powder for Oral SuspensionPSN9f6f0e30-7eba-45eb-927a-f7150b043d43101
1801279Sugar-Free cholestyramine resin 4000 MG Powder for Oral SuspensionSCD9f6f0e30-7eba-45eb-927a-f7150b043d43101
1801279cholestyramine Sugar-Free 4 GM Powder for Oral SuspensionSY9f6f0e30-7eba-45eb-927a-f7150b043d43101
1801279cholestyramine Sugar-Free 4 GM Powder for Oral SuspensionPSN4c9d4561-d5b5-463b-ac57-1bc4d84d135d6
1801279Sugar-Free cholestyramine resin 4000 MG Powder for Oral SuspensionSCD4c9d4561-d5b5-463b-ac57-1bc4d84d135d6
1801279cholestyramine Sugar-Free 4 GM Powder for Oral SuspensionSY4c9d4561-d5b5-463b-ac57-1bc4d84d135d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-422-2467877042224240.156 g in 1 JAR (67877-422-24) 240.156 g2021-10-200000-00-00NoNoCurrent
67877-422-57678770422575.718 g in 1 POUCH5.718 gHistorical
67877-422-606787704226060 POUCH in 1 CARTON (67877-422-60) / 5.718 g in 1 POUCH (67877-422-57) 60 pouch2021-10-200000-00-00NoNoCurrent