FDA.reportPublic FDA data

ezetimibe and simvastatin

Product NDC
68462-321
11-digit product format
684620321
Labeler code
68462
Product ID
68462-321_9c80244b-f111-425c-bf4c-c8cc91300cce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ezetimibe and simvastatin
Dosage form
TABLET
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA208699
Marketing category
ANDA
Marketing start
2019-06-27
Substance
EZETIMIBE; SIMVASTATIN
Active strength
10; 10 mg/1; mg/1
Pharmacologic classes
Decreased Cholesterol Absorption [PE], Dietary Cholesterol Absorption Inhibitor [EPC], HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ezetimibe and simvastatin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EZETIMIBE10 mg/1
SIMVASTATIN10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEOR26LQQ24, AGG2FN16EV
Rxcui476345, 476349, 476350, 476351

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5347abc9-d72b-9efb-f582-cc87efafcf1bProduct name420250729
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
43d7afbf-e4f7-4bf9-9d8f-6c620b3b3db6Product name120160615
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
46fdf265-6d5a-1bfb-93db-d82a4ea8aa81Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-321-10ezetimibe and simvastatin1000 in 1 BOTTLETABLET10006
68462-321-30ezetimibe and simvastatin30 in 1 BOTTLETABLET306
68462-321-90ezetimibe and simvastatin90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-321-30EA - Each68462-321a7ee23d7-b1cc-4b51-9625-d7a1d968a46812020-01-03
68462-321-90EA - Each68462-321bb43820c-7364-473b-9321-b5e61c99b28412020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-321EZETIMIBE AND SIMVASTATIN TABLET [GLENMARK PHARMACEUTICALS INC., USA]6Current NDC, Legacy NDC, 3 package rows20240501_32d0e130-1211-44ca-be60-5379ffec96fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476345ezetimibe 10 MG / simvastatin 10 MG Oral TabletPSN32d0e130-1211-44ca-be60-5379ffec96fd6
476349ezetimibe 10 MG / simvastatin 20 MG Oral TabletPSN32d0e130-1211-44ca-be60-5379ffec96fd6
476350ezetimibe 10 MG / simvastatin 40 MG Oral TabletPSN32d0e130-1211-44ca-be60-5379ffec96fd6
476351ezetimibe 10 MG / simvastatin 80 MG Oral TabletPSN32d0e130-1211-44ca-be60-5379ffec96fd6
476345ezetimibe 10 MG / simvastatin 10 MG Oral TabletSCD32d0e130-1211-44ca-be60-5379ffec96fd6
476349ezetimibe 10 MG / simvastatin 20 MG Oral TabletSCD32d0e130-1211-44ca-be60-5379ffec96fd6
476350ezetimibe 10 MG / simvastatin 40 MG Oral TabletSCD32d0e130-1211-44ca-be60-5379ffec96fd6
476351ezetimibe 10 MG / simvastatin 80 MG Oral TabletSCD32d0e130-1211-44ca-be60-5379ffec96fd6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-321-10684620321101000 TABLET in 1 BOTTLE (68462-321-10) 1000 tablet2019-06-270000-00-00NoNoCurrent
68462-321-306846203213030 TABLET in 1 BOTTLE (68462-321-30) 30 tablet2019-06-270000-00-00NoNoCurrent
68462-321-906846203219090 TABLET in 1 BOTTLE (68462-321-90) 90 tablet2019-06-270000-00-00NoNoCurrent