FDA.reportPublic FDA data

Ezetimibe

Product NDC
68462-226
11-digit product format
684620226
Labeler code
68462
Product ID
68462-226_5009c162-91bb-425a-a688-6237c259d33e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe
Dosage form
TABLET
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA078560
Marketing category
ANDA
Marketing start
2022-04-29
Marketing end
2027-01-01
Substance
EZETIMIBE
Active strength
10 mg/1
Pharmacologic classes
Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ezetimibe

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EZETIMIBE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEOR26LQQ24
Rxcui349556

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
91774e91-b249-45e3-8ff8-4b5db2927a69Product name120230718
93a156a6-903b-1690-4dc3-a57adfaa8c1aProduct name920230322
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
b249faa8-b784-47ef-8ad4-031ef248fa73Product name120200626
c4422d73-8e69-1539-606a-32a25fa00ebcProduct name420190926
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-226-05Ezetimibe500 in 1 BOTTLETABLET50011
68462-226-10Ezetimibe1000 in 1 BOTTLETABLET100011
68462-226-11Ezetimibe10 in 1 BLISTER PACKTABLET1011
68462-226-11Ezetimibe10 in 1 CARTONTABLET1011
68462-226-30Ezetimibe30 in 1 BOTTLETABLET3011
68462-226-90Ezetimibe90 in 1 BOTTLETABLET9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-226-05EA - Each68462-22675d0a943-086c-4437-a73a-957afaf728b612022-05-04
68462-226-30EA - Each68462-22642e97552-4158-4102-b192-cadd8ed11dfa12022-05-04
68462-226-90EA - Each68462-2266d8cdd78-e31b-4beb-9857-8956a5df1e6d12022-05-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EZETIMIBEACTIVE INGREDIENTEOR26LQQ24EZETIMIBE TABLET [GLENMARK GENERICS INC., USA]1
EZETIMIBEACTIVE MOIETYEOR26LQQ24EZETIMIBE TABLET [GLENMARK GENERICS INC., USA]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XEZETIMIBE TABLET [GLENMARK GENERICS INC., USA]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30EZETIMIBE TABLET [GLENMARK GENERICS INC., USA]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EEZETIMIBE TABLET [GLENMARK GENERICS INC., USA]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JEZETIMIBE TABLET [GLENMARK GENERICS INC., USA]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-226EZETIMIBE TABLET [GLENMARK PHARMACEUTICALS INC., USA]10Current NDC, Legacy NDC, 6 package rows20240426_ac539a72-77e4-419c-b1d9-42002e9cecf7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349556ezetimibe 10 MG Oral TabletPSNac539a72-77e4-419c-b1d9-42002e9cecf711
349556ezetimibe 10 MG Oral TabletSCDac539a72-77e4-419c-b1d9-42002e9cecf711
349556ezetimibe 10 MG Oral TabletPSN1afdb764-c5da-4982-beae-9be61bdcbcdc2
349556ezetimibe 10 MG Oral TabletSCD1afdb764-c5da-4982-beae-9be61bdcbcdc2
349556ezetimibe 10 MG Oral TabletPSN55b18d8f-40e0-48ba-baf1-79a0d1bb2ee21
349556ezetimibe 10 MG Oral TabletPSN5877150f-2807-435e-8e5b-a07dc7dbfd271
349556ezetimibe 10 MG Oral TabletSCD55b18d8f-40e0-48ba-baf1-79a0d1bb2ee21
349556ezetimibe 10 MG Oral TabletSCD5877150f-2807-435e-8e5b-a07dc7dbfd271

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-226-0568462022605500 TABLET in 1 BOTTLE (68462-226-05) 500 tablet2022-04-292027-01-01NoNoCurrent
68462-226-10684620226101000 TABLET in 1 BOTTLE (68462-226-10) 1000 tablet2022-04-292027-01-01NoNoCurrent
68462-226-116846202261110 BLISTER PACK in 1 CARTON (68462-226-11) / 10 TABLET in 1 BLISTER PACK10 blister pack2022-04-292027-01-01NoNoCurrent
68462-226-306846202263030 TABLET in 1 BOTTLE (68462-226-30) 30 tablet2022-04-292027-01-01NoNoCurrent
68462-226-906846202269090 TABLET in 1 BOTTLE (68462-226-90) 90 tablet2022-04-292027-01-01NoNoCurrent