FDA.reportPublic FDA data

Ezetimibe and Simvastatin

Product NDC
59651-837
11-digit product format
596510837
Labeler code
59651
Product ID
59651-837_0d4244dd-a226-4677-a6b2-6a1b5cd88790
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ezetimibe and Simvastatin
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA200082
Marketing category
ANDA
Marketing start
2024-03-01
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
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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
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
59651-837-30Ezetimibe and Simvastatin30 in 1 BOTTLETABLET303
59651-837-90Ezetimibe and Simvastatin90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-837EZETIMIBE AND SIMVASTATIN TABLET [AUROBINDO PHARMA LIMITED]3Current NDC, 2 package rows20241025_79dadfde-35c7-4937-9c82-1728fb6be2fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476345ezetimibe 10 MG / simvastatin 10 MG Oral TabletPSN79dadfde-35c7-4937-9c82-1728fb6be2fb3
476349ezetimibe 10 MG / simvastatin 20 MG Oral TabletPSN79dadfde-35c7-4937-9c82-1728fb6be2fb3
476350ezetimibe 10 MG / simvastatin 40 MG Oral TabletPSN79dadfde-35c7-4937-9c82-1728fb6be2fb3
476351ezetimibe 10 MG / simvastatin 80 MG Oral TabletPSN79dadfde-35c7-4937-9c82-1728fb6be2fb3
476345ezetimibe 10 MG / simvastatin 10 MG Oral TabletSCD79dadfde-35c7-4937-9c82-1728fb6be2fb3
476349ezetimibe 10 MG / simvastatin 20 MG Oral TabletSCD79dadfde-35c7-4937-9c82-1728fb6be2fb3
476350ezetimibe 10 MG / simvastatin 40 MG Oral TabletSCD79dadfde-35c7-4937-9c82-1728fb6be2fb3
476351ezetimibe 10 MG / simvastatin 80 MG Oral TabletSCD79dadfde-35c7-4937-9c82-1728fb6be2fb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-837-305965108373030 TABLET in 1 BOTTLE (59651-837-30) 30 tablet2024-03-01NoNoHistorical
59651-837-905965108379090 TABLET in 1 BOTTLE (59651-837-90) 90 tablet2024-03-01NoNoHistorical