FDA.reportPublic FDA data

ezetimibe and simvastatin

Product NDC
50090-7047
11-digit product format
500907047
Labeler code
50090
Product ID
50090-7047_2a454f7c-e824-4504-b2e8-5fce64b1065a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ezetimibe and simvastatin
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208699
Marketing category
ANDA
Marketing start
2019-08-19
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
UniiEOR26LQQ24, AGG2FN16EV
Rxcui476350

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
50090-7047-0ezetimibe and simvastatin90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7047-0EA - Each50090-704769577366-d49b-41a2-b347-63faf9fa945412024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7047EZETIMIBE AND SIMVASTATIN TABLET [A-S MEDICATION SOLUTIONS]1Current NDC, 1 package rows20240117_2c936363-b483-46c6-936c-a07d8ab0280c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476350ezetimibe 10 MG / simvastatin 40 MG Oral TabletPSN2c936363-b483-46c6-936c-a07d8ab0280c1
476350ezetimibe 10 MG / simvastatin 40 MG Oral TabletSCD2c936363-b483-46c6-936c-a07d8ab0280c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7047-05009070470090 TABLET in 1 BOTTLE (50090-7047-0) 90 tablet2024-01-15NoNoHistorical