FDA.reportPublic FDA data

Ezetimibe and Simvastatin

Product NDC
51407-192
11-digit product format
514070192
Labeler code
51407
Product ID
51407-192_446023ff-25b4-2c12-e063-6294a90ad27e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe and Simvastatin
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA200909
Marketing category
ANDA
Marketing start
2017-04-26
Marketing end
2027-09-30
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ezetimibe and Simvastatin

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EZETIMIBE10 mg/1
SIMVASTATIN40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEOR26LQQ24, AGG2FN16EV
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
51407-192-05Ezetimibe and Simvastatin500 in 1 BOTTLETABLET5007
51407-192-10Ezetimibe and Simvastatin1000 in 1 BOTTLETABLET10007
51407-192-30Ezetimibe and Simvastatin30 in 1 BOTTLETABLET307
51407-192-90Ezetimibe and Simvastatin90 in 1 BOTTLETABLET907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-192EZETIMIBE AND SIMVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY]6Current NDC, Legacy NDC, 4 package rows20231215_88cd0e7b-e8dc-6125-e053-2a95a90aaa27.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476345ezetimibe 10 MG / simvastatin 10 MG Oral TabletPSN88cd0e7b-e8dc-6125-e053-2a95a90aaa277
476349ezetimibe 10 MG / simvastatin 20 MG Oral TabletPSN88cd0e7b-e8dc-6125-e053-2a95a90aaa277
476350ezetimibe 10 MG / simvastatin 40 MG Oral TabletPSN88cd0e7b-e8dc-6125-e053-2a95a90aaa277
476351ezetimibe 10 MG / simvastatin 80 MG Oral TabletPSN88cd0e7b-e8dc-6125-e053-2a95a90aaa277
476345ezetimibe 10 MG / simvastatin 10 MG Oral TabletSCD88cd0e7b-e8dc-6125-e053-2a95a90aaa277
476349ezetimibe 10 MG / simvastatin 20 MG Oral TabletSCD88cd0e7b-e8dc-6125-e053-2a95a90aaa277
476350ezetimibe 10 MG / simvastatin 40 MG Oral TabletSCD88cd0e7b-e8dc-6125-e053-2a95a90aaa277
476351ezetimibe 10 MG / simvastatin 80 MG Oral TabletSCD88cd0e7b-e8dc-6125-e053-2a95a90aaa277

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51407-192-0551407019205500 TABLET in 1 BOTTLE (51407-192-05) 500 tablet2019-04-290000-00-00NoNoCurrent
51407-192-10514070192101000 TABLET in 1 BOTTLE (51407-192-10) 1000 tablet2019-04-290000-00-00NoNoCurrent
51407-192-305140701923030 TABLET in 1 BOTTLE (51407-192-30) 30 tablet2019-04-292027-09-30NoNoCurrent
51407-192-905140701929090 TABLET in 1 BOTTLE (51407-192-90) 90 tablet2019-04-290000-00-00NoNoCurrent