FDA.reportPublic FDA data

VYTORIN

Product NDC
66582-311
11-digit product format
665820311
Labeler code
66582
Product ID
66582-311_601cfe1f-9a31-4f9d-85fb-27bad0191acf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ezetimibe and simvastatin
Dosage form
TABLET
Route
ORAL
Labeler
Merck Sharp & Dohme 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
No
Listing certified through
2022-12-31
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66582-311-31EA - Each66582-31103b64cf0-6fc8-470e-b49d-8d81fce2f66e12012-07-24
66582-311-54EA - Each66582-311cb586942-6d4c-4305-a4d5-f0575e589b2012012-07-24
66582-311-82EA - Each66582-3115324c251-0a7a-481b-839e-2b77a2c2bd1c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ezetimibeACTIVE INGREDIENTEOR26LQQ24VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]2
simvastatinACTIVE INGREDIENTAGG2FN16EVVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]2
ezetimibeACTIVE MOIETYEOR26LQQ24VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]2
simvastatinACTIVE MOIETYAGG2FN16EVVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]2
butylated hydroxyanisoleINACTIVE INGREDIENTREK4960K2UVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]2
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]2
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]2
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XVYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]2
propyl gallateINACTIVE INGREDIENT8D4SNN7V92VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [PHYSICIANS TOTAL CARE, INC.]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476345ezetimibe 10 MG / simvastatin 10 MG Oral TabletPSN2507c644-e445-4e31-8d15-82afcb15f2742
476349ezetimibe 10 MG / simvastatin 20 MG Oral TabletPSN2507c644-e445-4e31-8d15-82afcb15f2742
476350ezetimibe 10 MG / simvastatin 40 MG Oral TabletPSN2507c644-e445-4e31-8d15-82afcb15f2742
476351ezetimibe 10 MG / simvastatin 80 MG Oral TabletPSN2507c644-e445-4e31-8d15-82afcb15f2742
1245420Vytorin 10 MG / 10 MG Oral TabletPSN2507c644-e445-4e31-8d15-82afcb15f2742
1245430Vytorin 10 MG / 20 MG Oral TabletPSN2507c644-e445-4e31-8d15-82afcb15f2742
1245441Vytorin 10 MG / 40 MG Oral TabletPSN2507c644-e445-4e31-8d15-82afcb15f2742
1245449Vytorin 10 MG / 80 MG Oral TabletPSN2507c644-e445-4e31-8d15-82afcb15f2742
1245420ezetimibe 10 MG / simvastatin 10 MG Oral Tablet [Vytorin]SBD2507c644-e445-4e31-8d15-82afcb15f2742
1245430ezetimibe 10 MG / simvastatin 20 MG Oral Tablet [Vytorin]SBD2507c644-e445-4e31-8d15-82afcb15f2742
1245441ezetimibe 10 MG / simvastatin 40 MG Oral Tablet [Vytorin]SBD2507c644-e445-4e31-8d15-82afcb15f2742
1245449ezetimibe 10 MG / simvastatin 80 MG Oral Tablet [Vytorin]SBD2507c644-e445-4e31-8d15-82afcb15f2742
476345ezetimibe 10 MG / simvastatin 10 MG Oral TabletSCD2507c644-e445-4e31-8d15-82afcb15f2742
476349ezetimibe 10 MG / simvastatin 20 MG Oral TabletSCD2507c644-e445-4e31-8d15-82afcb15f2742
476350ezetimibe 10 MG / simvastatin 40 MG Oral TabletSCD2507c644-e445-4e31-8d15-82afcb15f2742
476351ezetimibe 10 MG / simvastatin 80 MG Oral TabletSCD2507c644-e445-4e31-8d15-82afcb15f2742
1245420Vytorin 10/10 (ezetimibe 10 MG / simvastatin 10 MG) Oral TabletSY2507c644-e445-4e31-8d15-82afcb15f2742
1245420Vytorin 10/10 Oral TabletSY2507c644-e445-4e31-8d15-82afcb15f2742
1245430Vytorin 10/20 (ezetimibe 10 MG / simvastatin 20 MG) Oral TabletSY2507c644-e445-4e31-8d15-82afcb15f2742
1245430Vytorin 10/20 Oral TabletSY2507c644-e445-4e31-8d15-82afcb15f2742
1245441Vytorin 10/40 (ezetimibe 10 MG / simvastatin 40 MG) Oral TabletSY2507c644-e445-4e31-8d15-82afcb15f2742
1245441Vytorin 10/40 Oral TabletSY2507c644-e445-4e31-8d15-82afcb15f2742
1245449Vytorin 10/80 (ezetimibe 10 MG / simvastatin 80 MG) Oral TabletSY2507c644-e445-4e31-8d15-82afcb15f2742
1245449Vytorin 10/80 Oral TabletSY2507c644-e445-4e31-8d15-82afcb15f2742

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66582-311-316658203113130 TABLET in 1 BOTTLE (66582-311-31) 30 tablet2004-07-230000-00-00NoNoCurrent
66582-311-546658203115490 TABLET in 1 BOTTLE (66582-311-54) 90 tablet2004-07-230000-00-00NoNoCurrent
66582-311-876658203118710000 TABLET in 1 BOTTLE (66582-311-87) 10000 tablet2004-07-230000-00-00NoNoCurrent