ezetimibe

Generic: ezetimibe

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ezetimibe
Generic Name ezetimibe
Labeler zydus lifesciences limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ezetimibe 10 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1109
Product ID 70771-1109_5862da1c-e73d-44ff-a961-aaef469ed646
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204331
Listing Expiration 2026-12-31
Marketing Start 2017-08-09

Pharmacologic Class

Established (EPC)
dietary cholesterol absorption inhibitor [epc]
Physiologic Effect
decreased cholesterol absorption [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707711109
Hyphenated Format 70771-1109

Supplemental Identifiers

RxCUI
349556
UNII
EOR26LQQ24
NUI
N0000008553 N0000175911

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 (source: ndc)
Generic Name ezetimibe (source: ndc)
Application Number ANDA204331 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (70771-1109-0)
  • 100 TABLET in 1 BOTTLE (70771-1109-1)
  • 30 TABLET in 1 BOTTLE (70771-1109-3)
  • 10 BLISTER PACK in 1 CARTON (70771-1109-4) / 10 TABLET in 1 BLISTER PACK (70771-1109-2)
  • 500 TABLET in 1 BOTTLE (70771-1109-5)
  • 90 TABLET in 1 BOTTLE (70771-1109-9)
source: ndc

Packages (6)

70771-1109-0 1000 TABLET in 1 BOTTLE (70771-1109-0) 70771-1109-1 100 TABLET in 1 BOTTLE (70771-1109-1) 70771-1109-3 30 TABLET in 1 BOTTLE (70771-1109-3) 70771-1109-4 10 BLISTER PACK in 1 CARTON (70771-1109-4) / 10 TABLET in 1 BLISTER PACK (70771-1109-2) 70771-1109-5 500 TABLET in 1 BOTTLE (70771-1109-5) 70771-1109-9 90 TABLET in 1 BOTTLE (70771-1109-9)

Ingredients (1)

ezetimibe (10 mg/1)

Linked Drug Pages (1)

ezetimibe ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5862da1c-e73d-44ff-a961-aaef469ed646", "openfda": {"nui": ["N0000008553", "N0000175911"], "unii": ["EOR26LQQ24"], "rxcui": ["349556"], "spl_set_id": ["de814dcd-4759-4e9c-a650-335fb885a79d"], "pharm_class_pe": ["Decreased Cholesterol Absorption [PE]"], "pharm_class_epc": ["Dietary Cholesterol Absorption Inhibitor [EPC]"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (70771-1109-0)", "package_ndc": "70771-1109-0", "marketing_start_date": "20170809"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (70771-1109-1)", "package_ndc": "70771-1109-1", "marketing_start_date": "20170809"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (70771-1109-3)", "package_ndc": "70771-1109-3", "marketing_start_date": "20170809"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70771-1109-4)  / 10 TABLET in 1 BLISTER PACK (70771-1109-2)", "package_ndc": "70771-1109-4", "marketing_start_date": "20170809"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (70771-1109-5)", "package_ndc": "70771-1109-5", "marketing_start_date": "20170809"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (70771-1109-9)", "package_ndc": "70771-1109-9", "marketing_start_date": "20170809"}], "brand_name": "ezetimibe", "product_id": "70771-1109_5862da1c-e73d-44ff-a961-aaef469ed646", "dosage_form": "TABLET", "pharm_class": ["Decreased Cholesterol Absorption [PE]", "Dietary Cholesterol Absorption Inhibitor [EPC]"], "product_ndc": "70771-1109", "generic_name": "ezetimibe", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ezetimibe", "active_ingredients": [{"name": "EZETIMIBE", "strength": "10 mg/1"}], "application_number": "ANDA204331", "marketing_category": "ANDA", "marketing_start_date": "20170809", "listing_expiration_date": "20261231"}