FDA.reportPublic FDA data

VYTORIN

Product NDC
78206-177
11-digit product format
782060177
Labeler code
78206
Product ID
78206-177_9e668c78-ea5d-4099-ba16-b77aebbcb68a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ezetimibe and simvastatin
Dosage form
TABLET
Route
ORAL
Labeler
Organon LLC
Application
NDA021687
Marketing category
NDA
Marketing start
2021-06-01
Substance
EZETIMIBE; SIMVASTATIN
Active strength
10; 80 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VYTORIN
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EZETIMIBE10 mg/1
SIMVASTATIN80 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEOR26LQQ24, AGG2FN16EV
Rxcui476345, 476349, 476350, 476351, 1245420, 1245430, 1245441, 1245449

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
78206-177-01VYTORIN30 in 1 BOTTLETABLET309
78206-177-02VYTORIN90 in 1 BOTTLETABLET909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
78206-177-01EA - Each78206-177144e0062-ab7a-486c-a025-9e685905d8cb12021-08-05
78206-177-02EA - Each78206-177da000e84-87e0-48af-a471-7b8f4895e21512021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78206-177VYTORIN (EZETIMIBE AND SIMVASTATIN) TABLET [ORGANON LLC]7Current NDC, Legacy NDC, 2 package rows20241123_89b860d2-de83-468e-b7e8-76aeec2edca2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476345ezetimibe 10 MG / simvastatin 10 MG Oral TabletPSN89b860d2-de83-468e-b7e8-76aeec2edca29
476349ezetimibe 10 MG / simvastatin 20 MG Oral TabletPSN89b860d2-de83-468e-b7e8-76aeec2edca29
476350ezetimibe 10 MG / simvastatin 40 MG Oral TabletPSN89b860d2-de83-468e-b7e8-76aeec2edca29
476351ezetimibe 10 MG / simvastatin 80 MG Oral TabletPSN89b860d2-de83-468e-b7e8-76aeec2edca29
1245420Vytorin 10 MG / 10 MG Oral TabletPSN89b860d2-de83-468e-b7e8-76aeec2edca29
1245430Vytorin 10 MG / 20 MG Oral TabletPSN89b860d2-de83-468e-b7e8-76aeec2edca29
1245441Vytorin 10 MG / 40 MG Oral TabletPSN89b860d2-de83-468e-b7e8-76aeec2edca29
1245449Vytorin 10 MG / 80 MG Oral TabletPSN89b860d2-de83-468e-b7e8-76aeec2edca29
1245420ezetimibe 10 MG / simvastatin 10 MG Oral Tablet [Vytorin]SBD89b860d2-de83-468e-b7e8-76aeec2edca29
1245430ezetimibe 10 MG / simvastatin 20 MG Oral Tablet [Vytorin]SBD89b860d2-de83-468e-b7e8-76aeec2edca29
1245441ezetimibe 10 MG / simvastatin 40 MG Oral Tablet [Vytorin]SBD89b860d2-de83-468e-b7e8-76aeec2edca29
1245449ezetimibe 10 MG / simvastatin 80 MG Oral Tablet [Vytorin]SBD89b860d2-de83-468e-b7e8-76aeec2edca29
476345ezetimibe 10 MG / simvastatin 10 MG Oral TabletSCD89b860d2-de83-468e-b7e8-76aeec2edca29
476349ezetimibe 10 MG / simvastatin 20 MG Oral TabletSCD89b860d2-de83-468e-b7e8-76aeec2edca29
476350ezetimibe 10 MG / simvastatin 40 MG Oral TabletSCD89b860d2-de83-468e-b7e8-76aeec2edca29
476351ezetimibe 10 MG / simvastatin 80 MG Oral TabletSCD89b860d2-de83-468e-b7e8-76aeec2edca29
1245420Vytorin 10/10 (ezetimibe 10 MG / simvastatin 10 MG) Oral TabletSY89b860d2-de83-468e-b7e8-76aeec2edca29
1245420Vytorin 10/10 Oral TabletSY89b860d2-de83-468e-b7e8-76aeec2edca29
1245430Vytorin 10/20 (ezetimibe 10 MG / simvastatin 20 MG) Oral TabletSY89b860d2-de83-468e-b7e8-76aeec2edca29
1245430Vytorin 10/20 Oral TabletSY89b860d2-de83-468e-b7e8-76aeec2edca29
1245441Vytorin 10/40 (ezetimibe 10 MG / simvastatin 40 MG) Oral TabletSY89b860d2-de83-468e-b7e8-76aeec2edca29
1245441Vytorin 10/40 Oral TabletSY89b860d2-de83-468e-b7e8-76aeec2edca29
1245449Vytorin 10/80 (ezetimibe 10 MG / simvastatin 80 MG) Oral TabletSY89b860d2-de83-468e-b7e8-76aeec2edca29
1245449Vytorin 10/80 Oral TabletSY89b860d2-de83-468e-b7e8-76aeec2edca29

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78206-177-017820601770130 TABLET in 1 BOTTLE (78206-177-01) 30 tablet2021-06-010000-00-00NoNoCurrent
78206-177-027820601770290 TABLET in 1 BOTTLE (78206-177-02) 90 tablet2021-06-010000-00-00NoNoCurrent