FDA.reportPublic FDA data

Ezetimibe and Simvastatin

Product NDC
69238-1158
11-digit product format
692381158
Labeler code
69238
Product ID
69238-1158_331b2e88-9d76-4e41-bca7-bcff0e206614
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe and Simvastatin
Dosage form
TABLET
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA208831
Marketing category
ANDA
Marketing start
2017-11-21
Substance
EZETIMIBE; SIMVASTATIN
Active strength
10; 80 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
SIMVASTATIN80 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
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
69238-1158-3Ezetimibe and Simvastatin30 in 1 BOTTLETABLET3013
69238-1158-9Ezetimibe and Simvastatin90 in 1 BOTTLETABLET9013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1158-3EA - Each69238-11587a844803-8fc9-4f36-9f56-171e775370ad12018-01-12
69238-1158-9EA - Each69238-1158c6e5eb78-2639-44f7-87b7-904e2f4db9bd12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1158EZETIMIBE AND SIMVASTATIN TABLET [AMNEAL PHARMACEUTICALS NY LLC]13Current NDC, Legacy NDC, 2 package rows20250427_5ea3ca31-cfee-4978-8b7a-755986f6b091.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476345ezetimibe 10 MG / simvastatin 10 MG Oral TabletPSN5ea3ca31-cfee-4978-8b7a-755986f6b09113
476349ezetimibe 10 MG / simvastatin 20 MG Oral TabletPSN5ea3ca31-cfee-4978-8b7a-755986f6b09113
476350ezetimibe 10 MG / simvastatin 40 MG Oral TabletPSN5ea3ca31-cfee-4978-8b7a-755986f6b09113
476351ezetimibe 10 MG / simvastatin 80 MG Oral TabletPSN5ea3ca31-cfee-4978-8b7a-755986f6b09113
476345ezetimibe 10 MG / simvastatin 10 MG Oral TabletSCD5ea3ca31-cfee-4978-8b7a-755986f6b09113
476349ezetimibe 10 MG / simvastatin 20 MG Oral TabletSCD5ea3ca31-cfee-4978-8b7a-755986f6b09113
476350ezetimibe 10 MG / simvastatin 40 MG Oral TabletSCD5ea3ca31-cfee-4978-8b7a-755986f6b09113
476351ezetimibe 10 MG / simvastatin 80 MG Oral TabletSCD5ea3ca31-cfee-4978-8b7a-755986f6b09113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1158-36923811580330 TABLET in 1 BOTTLE (69238-1158-3) 30 tablet2017-11-210000-00-00NoNoCurrent
69238-1158-96923811580990 TABLET in 1 BOTTLE (69238-1158-9) 90 tablet2017-11-210000-00-00NoNoCurrent