FDA.reportPublic FDA data

Ezetimibe and Simvastatin

Product NDC
50090-4772
11-digit product format
500904772
Labeler code
50090
Product ID
50090-4772_c47669cc-ed22-4780-804f-d5859d01dff9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe and Simvastatin
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ezetimibe and Simvastatin
Listing expiration
2027-12-31

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4772-02023-02-07C16284748780-1f386c64a-417b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use EZETIMIBE AND SIMVASTATIN TABLETS safely and effectively. See full prescribing information for EZETIMIBE AND SIMVASTATIN TABLETS. EZETIMIBE and SIMVASTATIN tablets, for oral use Initial U.S. Approval: 2004
50090-4772-02023-01-30C16284748780-1f386c64a-417b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use EZETIMIBE AND SIMVASTATIN TABLETS safely and effectively. See full prescribing information for EZETIMIBE AND SIMVASTATIN TABLETS. EZETIMIBE and SIMVASTATIN tablets, for oral use Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4772-0Ezetimibe and Simvastatin90 in 1 BOTTLETABLET907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4772EZETIMIBE AND SIMVASTATIN TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 1 package rows20230208_2ce219a2-1eeb-4ece-bb87-3810e593ca51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
50090-4772-05009047720090 TABLET in 1 BOTTLE (50090-4772-0) 90 tablet2019-12-020000-00-00NoNoCurrent