Ezetimibe and Simvastatin

Product NDC
50090-3984
11-digit product format
500903984
Labeler code
50090
Product ID
50090-3984_61f1a059-0309-4d53-a8d8-ab73fbf6886c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe and Simvastatin
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208831
Marketing category
ANDA
Marketing start
2018-09-24
Marketing end
0000-00-00
Substance
EZETIMIBE; SIMVASTATIN
Active strength
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
2020-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3984-0Ezetimibe and Simvastatin90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3984-0EA - Each50090-3984c707fa49-7789-4dba-8f78-fad18c28e35012021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3984EZETIMIBE AND SIMVASTATIN TABLET [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20190103_fc205122-d66a-41cc-bfce-8e4c109f2f50.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476350ezetimibe 10 MG / simvastatin 40 MG Oral TabletPSNfc205122-d66a-41cc-bfce-8e4c109f2f501
476350ezetimibe 10 MG / simvastatin 40 MG Oral TabletSCDfc205122-d66a-41cc-bfce-8e4c109f2f501

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3984-05009039840090 TABLET in 1 BOTTLE (50090-3984-0) 90 tablet2018-12-170000-00-00NoNoCurrent