vytorin

Generic: ezetimibe and simvastatin

Labeler: organon llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name vytorin
Generic Name ezetimibe and simvastatin
Labeler organon llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ezetimibe 10 mg/1, simvastatin 80 mg/1

Manufacturer
Organon LLC

Identifiers & Regulatory

Product NDC 78206-177
Product ID 78206-177_9e668c78-ea5d-4099-ba16-b77aebbcb68a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021687
Listing Expiration 2027-12-31
Marketing Start 2021-06-01

Pharmacologic Class

Established (EPC)
dietary cholesterol absorption inhibitor [epc] hmg-coa reductase inhibitor [epc]
Mechanism of Action
hydroxymethylglutaryl-coa reductase inhibitors [moa]
Physiologic Effect
decreased cholesterol absorption [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 78206177
Hyphenated Format 78206-177

Supplemental Identifiers

RxCUI
476345 476349 476350 476351 1245420 1245430 1245441 1245449
UPC
0378206174017 0378206175014 0378206176011 0378206177018
UNII
EOR26LQQ24 AGG2FN16EV
NUI
N0000008553 N0000175911 N0000175589 N0000000121

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name vytorin (source: ndc)
Generic Name ezetimibe and simvastatin (source: ndc)
Application Number NDA021687 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
  • 80 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (78206-177-01)
  • 90 TABLET in 1 BOTTLE (78206-177-02)
source: ndc

Packages (2)

78206-177-01 30 TABLET in 1 BOTTLE (78206-177-01) 78206-177-02 90 TABLET in 1 BOTTLE (78206-177-02)

Ingredients (2)

ezetimibe (10 mg/1) simvastatin (80 mg/1)

Linked Drug Pages (1)

VYTORIN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "9e668c78-ea5d-4099-ba16-b77aebbcb68a", "openfda": {"nui": ["N0000008553", "N0000175911", "N0000175589", "N0000000121"], "upc": ["0378206174017", "0378206175014", "0378206176011", "0378206177018"], "unii": ["EOR26LQQ24", "AGG2FN16EV"], "rxcui": ["476345", "476349", "476350", "476351", "1245420", "1245430", "1245441", "1245449"], "spl_set_id": ["89b860d2-de83-468e-b7e8-76aeec2edca2"], "pharm_class_pe": ["Decreased Cholesterol Absorption [PE]"], "pharm_class_epc": ["Dietary Cholesterol Absorption Inhibitor [EPC]", "HMG-CoA Reductase Inhibitor [EPC]"], "pharm_class_moa": ["Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "manufacturer_name": ["Organon LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (78206-177-01)", "package_ndc": "78206-177-01", "marketing_start_date": "20210601"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (78206-177-02)", "package_ndc": "78206-177-02", "marketing_start_date": "20210601"}], "brand_name": "VYTORIN", "product_id": "78206-177_9e668c78-ea5d-4099-ba16-b77aebbcb68a", "dosage_form": "TABLET", "pharm_class": ["Decreased Cholesterol Absorption [PE]", "Dietary Cholesterol Absorption Inhibitor [EPC]", "HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "78206-177", "generic_name": "ezetimibe and simvastatin", "labeler_name": "Organon LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "VYTORIN", "active_ingredients": [{"name": "EZETIMIBE", "strength": "10 mg/1"}, {"name": "SIMVASTATIN", "strength": "80 mg/1"}], "application_number": "NDA021687", "marketing_category": "NDA", "marketing_start_date": "20210601", "listing_expiration_date": "20271231"}