FDA.reportPublic FDA data

VYTORIN

Product NDC
21695-339
11-digit product format
216950339
Labeler code
21695
Product ID
21695-339_65e1c3ae-a462-4345-8a28-c7d2c0388af8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ezetimibe and simvastatin
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA021687
Marketing category
NDA
Marketing start
2004-07-23
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
E
Listing certified through
2017-12-31
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-339-302019-09-24C16284748780-1934fe258-4b5d-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use VYTORIN safely and effectively. See full prescribing information for VYTORIN. VYTORIN (ezetimibe/simvastatin) Tablets Initial U.S. Approval: 2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-339-30VYTORIN30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-339-30EA - Each21695-33949705c7d-d634-489b-8170-ca53b41a50a012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ezetimibeACTIVE INGREDIENTEOR26LQQ24VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]1
simvastatinACTIVE INGREDIENTAGG2FN16EVVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]1
ezetimibeACTIVE MOIETYEOR26LQQ24VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]1
simvastatinACTIVE MOIETYAGG2FN16EVVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]1
butylated hydroxyanisoleINACTIVE INGREDIENTREK4960K2UVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]1
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]1
propyl gallateINACTIVE INGREDIENT8D4SNN7V92VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-339VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20101210_65e1c3ae-a462-4345-8a28-c7d2c0388af8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476349ezetimibe 10 MG / simvastatin 20 MG Oral TabletPSN65e1c3ae-a462-4345-8a28-c7d2c0388af81
476350ezetimibe 10 MG / simvastatin 40 MG Oral TabletPSN65e1c3ae-a462-4345-8a28-c7d2c0388af81
476351ezetimibe 10 MG / simvastatin 80 MG Oral TabletPSN65e1c3ae-a462-4345-8a28-c7d2c0388af81
1245430Vytorin 10 MG / 20 MG Oral TabletPSN65e1c3ae-a462-4345-8a28-c7d2c0388af81
1245441Vytorin 10 MG / 40 MG Oral TabletPSN65e1c3ae-a462-4345-8a28-c7d2c0388af81
1245449Vytorin 10 MG / 80 MG Oral TabletPSN65e1c3ae-a462-4345-8a28-c7d2c0388af81
1245430ezetimibe 10 MG / simvastatin 20 MG Oral Tablet [Vytorin]SBD65e1c3ae-a462-4345-8a28-c7d2c0388af81
1245441ezetimibe 10 MG / simvastatin 40 MG Oral Tablet [Vytorin]SBD65e1c3ae-a462-4345-8a28-c7d2c0388af81
1245449ezetimibe 10 MG / simvastatin 80 MG Oral Tablet [Vytorin]SBD65e1c3ae-a462-4345-8a28-c7d2c0388af81
476349ezetimibe 10 MG / simvastatin 20 MG Oral TabletSCD65e1c3ae-a462-4345-8a28-c7d2c0388af81
476350ezetimibe 10 MG / simvastatin 40 MG Oral TabletSCD65e1c3ae-a462-4345-8a28-c7d2c0388af81
476351ezetimibe 10 MG / simvastatin 80 MG Oral TabletSCD65e1c3ae-a462-4345-8a28-c7d2c0388af81
1245430Vytorin 10/20 (ezetimibe 10 MG / simvastatin 20 MG) Oral TabletSY65e1c3ae-a462-4345-8a28-c7d2c0388af81
1245430Vytorin 10/20 Oral TabletSY65e1c3ae-a462-4345-8a28-c7d2c0388af81
1245441Vytorin 10/40 (ezetimibe 10 MG / simvastatin 40 MG) Oral TabletSY65e1c3ae-a462-4345-8a28-c7d2c0388af81
1245441Vytorin 10/40 Oral TabletSY65e1c3ae-a462-4345-8a28-c7d2c0388af81
1245449Vytorin 10/80 (ezetimibe 10 MG / simvastatin 80 MG) Oral TabletSY65e1c3ae-a462-4345-8a28-c7d2c0388af81
1245449Vytorin 10/80 Oral TabletSY65e1c3ae-a462-4345-8a28-c7d2c0388af81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-339-302169503393030 in 1 BOTTLEHistorical