FDA.reportPublic FDA data

Ezetimibe and Simvastatin

Product NDC
67877-509
11-digit product format
678770509
Labeler code
67877
Product ID
67877-509_ca1a42e2-f129-462a-8e87-a034da71862b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe and Simvastatin
Dosage form
TABLET
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA209222
Marketing category
ANDA
Marketing start
2017-12-24
Substance
EZETIMIBE; SIMVASTATIN
Active strength
10; 40 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
SIMVASTATIN40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiAGG2FN16EV, EOR26LQQ24
Rxcui476345, 476349, 476350, 476351

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5347abc9-d72b-9efb-f582-cc87efafcf1bProduct name420250729
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
67877-509-05Ezetimibe and Simvastatin500 in 1 BOTTLETABLET50016
67877-509-30Ezetimibe and Simvastatin30 in 1 BOTTLETABLET3016
67877-509-33Ezetimibe and Simvastatin10 in 1 BLISTER PACKTABLET1016
67877-509-37Ezetimibe and Simvastatin05 in 1 CARTONTABLET0516
67877-509-90Ezetimibe and Simvastatin90 in 1 BOTTLETABLET9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-509-05EA - Each67877-5098e994b79-4ec0-4a10-a56f-640acfdfc67612020-09-14
67877-509-30EA - Each67877-509dbdc54c5-8257-4657-9191-3d02940f5eab12018-02-20
67877-509-90EA - Each67877-5096fa0837d-de13-4d25-a362-0842591ff59f12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-509EZETIMIBE AND SIMVASTATIN TABLET [ASCEND LABORATORIES, LLC]16Current NDC, Legacy NDC, 5 package rows20250510_c90e8c96-e130-42d7-bf0d-5833652e40d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476345ezetimibe 10 MG / simvastatin 10 MG Oral TabletPSNc90e8c96-e130-42d7-bf0d-5833652e40d516
476349ezetimibe 10 MG / simvastatin 20 MG Oral TabletPSNc90e8c96-e130-42d7-bf0d-5833652e40d516
476350ezetimibe 10 MG / simvastatin 40 MG Oral TabletPSNc90e8c96-e130-42d7-bf0d-5833652e40d516
476351ezetimibe 10 MG / simvastatin 80 MG Oral TabletPSNc90e8c96-e130-42d7-bf0d-5833652e40d516
476345ezetimibe 10 MG / simvastatin 10 MG Oral TabletSCDc90e8c96-e130-42d7-bf0d-5833652e40d516
476349ezetimibe 10 MG / simvastatin 20 MG Oral TabletSCDc90e8c96-e130-42d7-bf0d-5833652e40d516
476350ezetimibe 10 MG / simvastatin 40 MG Oral TabletSCDc90e8c96-e130-42d7-bf0d-5833652e40d516
476351ezetimibe 10 MG / simvastatin 80 MG Oral TabletSCDc90e8c96-e130-42d7-bf0d-5833652e40d516
476350ezetimibe 10 MG / simvastatin 40 MG Oral TabletPSN2ce219a2-1eeb-4ece-bb87-3810e593ca517
476350ezetimibe 10 MG / simvastatin 40 MG Oral TabletSCD2ce219a2-1eeb-4ece-bb87-3810e593ca517

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-509-0567877050905500 TABLET in 1 BOTTLE (67877-509-05) 500 tablet2017-12-240000-00-00NoNoCurrent
67877-509-306787705093030 TABLET in 1 BOTTLE (67877-509-30) 30 tablet2017-12-240000-00-00NoNoCurrent
67877-509-336787705093310 in 1 BLISTER PACKHistorical
67877-509-37678770509375 BLISTER PACK in 1 CARTON (67877-509-37) / 10 TABLET in 1 BLISTER PACK (67877-509-33) 5 blister pack2017-12-240000-00-00NoNoCurrent
67877-509-906787705099090 TABLET in 1 BOTTLE (67877-509-90) 90 tablet2017-12-240000-00-00NoNoCurrent