FDA.reportPublic FDA data

colesevelam hydrochloride

Product NDC
68462-433
11-digit product format
684620433
Labeler code
68462
Product ID
68462-433_169fb7d2-7872-46a4-99ab-94f46781348f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
colesevelam hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA203480
Marketing category
ANDA
Marketing start
2018-05-18
Substance
COLESEVELAM HYDROCHLORIDE
Active strength
625 mg/1
Pharmacologic classes
Bile Acid Sequestrant [EPC], Bile-acid Binding Activity [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
colesevelam hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COLESEVELAM HYDROCHLORIDE625 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP4SG24WI5Q
Rxcui866910

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
78368210-61ea-2003-e774-9745708f5823Product name920220328

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-433-18colesevelam hydrochloride180 in 1 BOTTLETABLET, FILM COATED18014
68462-433-90colesevelam hydrochloride90 in 1 BOTTLETABLET, FILM COATED9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-433-18EA - Each68462-43317e2a56f-ebf6-490b-99e1-765663e42ca212018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-433COLESEVELAM HYDROCHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA]13Current NDC, Legacy NDC, 2 package rows20230414_845b8661-0aa9-418f-a496-df3d7a3130ff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
866910colesevelam HCl 625 MG Oral TabletPSN845b8661-0aa9-418f-a496-df3d7a3130ff14
866910colesevelam hydrochloride 625 MG Oral TabletSCD845b8661-0aa9-418f-a496-df3d7a3130ff14
866910colesevelam HCl 625 MG Oral TabletPSN67820d4f-0cfb-43ca-8974-08dffe4749831
866910colesevelam HCl 625 MG Oral TabletPSN79af88a5-b873-499b-a9a4-fc39624820fe1
866910colesevelam hydrochloride 625 MG Oral TabletSCD67820d4f-0cfb-43ca-8974-08dffe4749831
866910colesevelam hydrochloride 625 MG Oral TabletSCD79af88a5-b873-499b-a9a4-fc39624820fe1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68462-433-1868462043318180 TABLET, FILM COATED in 1 BOTTLE (68462-433-18) 2018-05-180000-00-00NoNoCurrent
68462-433-906846204339090 TABLET, FILM COATED in 1 BOTTLE (68462-433-90) 2018-05-180000-00-00NoNoCurrent