ezetimibe and simvastatin

Generic: ezetimibe and simvastatin

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ezetimibe and simvastatin
Generic Name ezetimibe and simvastatin
Labeler ascend laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ezetimibe 10 mg/1, simvastatin 80 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-510
Product ID 67877-510_ca1a42e2-f129-462a-8e87-a034da71862b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209222
Listing Expiration 2026-12-31
Marketing Start 2017-12-24

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 67877510
Hyphenated Format 67877-510

Supplemental Identifiers

RxCUI
476345 476349 476350 476351
UPC
0367877507309 0367877510057 0367877508016 0367877509907
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 ezetimibe and simvastatin (source: ndc)
Generic Name ezetimibe and simvastatin (source: ndc)
Application Number ANDA209222 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
  • 80 mg/1
source: ndc
Packaging
  • 500 TABLET in 1 BOTTLE (67877-510-05)
  • 30 TABLET in 1 BOTTLE (67877-510-30)
  • 5 BLISTER PACK in 1 CARTON (67877-510-37) / 10 TABLET in 1 BLISTER PACK (67877-510-33)
  • 90 TABLET in 1 BOTTLE (67877-510-90)
source: ndc

Packages (4)

67877-510-05 500 TABLET in 1 BOTTLE (67877-510-05) 67877-510-30 30 TABLET in 1 BOTTLE (67877-510-30) 67877-510-37 5 BLISTER PACK in 1 CARTON (67877-510-37) / 10 TABLET in 1 BLISTER PACK (67877-510-33) 67877-510-90 90 TABLET in 1 BOTTLE (67877-510-90)

Ingredients (2)

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

Linked Drug Pages (1)

Ezetimibe and Simvastatin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ca1a42e2-f129-462a-8e87-a034da71862b", "openfda": {"nui": ["N0000008553", "N0000175911", "N0000175589", "N0000000121"], "upc": ["0367877507309", "0367877510057", "0367877508016", "0367877509907"], "unii": ["EOR26LQQ24", "AGG2FN16EV"], "rxcui": ["476345", "476349", "476350", "476351"], "spl_set_id": ["c90e8c96-e130-42d7-bf0d-5833652e40d5"], "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": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET in 1 BOTTLE (67877-510-05)", "package_ndc": "67877-510-05", "marketing_start_date": "20171224"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (67877-510-30)", "package_ndc": "67877-510-30", "marketing_start_date": "20171224"}, {"sample": false, "description": "5 BLISTER PACK in 1 CARTON (67877-510-37)  / 10 TABLET in 1 BLISTER PACK (67877-510-33)", "package_ndc": "67877-510-37", "marketing_start_date": "20171224"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (67877-510-90)", "package_ndc": "67877-510-90", "marketing_start_date": "20171224"}], "brand_name": "Ezetimibe and Simvastatin", "product_id": "67877-510_ca1a42e2-f129-462a-8e87-a034da71862b", "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": "67877-510", "generic_name": "Ezetimibe and Simvastatin", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ezetimibe and Simvastatin", "active_ingredients": [{"name": "EZETIMIBE", "strength": "10 mg/1"}, {"name": "SIMVASTATIN", "strength": "80 mg/1"}], "application_number": "ANDA209222", "marketing_category": "ANDA", "marketing_start_date": "20171224", "listing_expiration_date": "20261231"}