ezetimibe

Generic: ezetimibe

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ezetimibe
Generic Name ezetimibe
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ezetimibe 10 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-773
Product ID 68382-773_ebb60f24-14be-4be0-b5e2-31e695eae876
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 68382773
Hyphenated Format 68382-773

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
  • 100 TABLET in 1 BOTTLE (68382-773-01)
  • 500 TABLET in 1 BOTTLE (68382-773-05)
  • 30 TABLET in 1 BOTTLE (68382-773-06)
  • 1000 TABLET in 1 BOTTLE (68382-773-10)
  • 90 TABLET in 1 BOTTLE (68382-773-16)
  • 10 BLISTER PACK in 1 CARTON (68382-773-77) / 10 TABLET in 1 BLISTER PACK (68382-773-30)
source: ndc

Packages (6)

68382-773-01 100 TABLET in 1 BOTTLE (68382-773-01) 68382-773-05 500 TABLET in 1 BOTTLE (68382-773-05) 68382-773-06 30 TABLET in 1 BOTTLE (68382-773-06) 68382-773-10 1000 TABLET in 1 BOTTLE (68382-773-10) 68382-773-16 90 TABLET in 1 BOTTLE (68382-773-16) 68382-773-77 10 BLISTER PACK in 1 CARTON (68382-773-77) / 10 TABLET in 1 BLISTER PACK (68382-773-30)

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": "ebb60f24-14be-4be0-b5e2-31e695eae876", "openfda": {"nui": ["N0000008553", "N0000175911"], "unii": ["EOR26LQQ24"], "rxcui": ["349556"], "spl_set_id": ["f852b12f-e25f-415b-b1e2-58955d609507"], "pharm_class_pe": ["Decreased Cholesterol Absorption [PE]"], "pharm_class_epc": ["Dietary Cholesterol Absorption Inhibitor [EPC]"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68382-773-01)", "package_ndc": "68382-773-01", "marketing_start_date": "20170809"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (68382-773-05)", "package_ndc": "68382-773-05", "marketing_start_date": "20170809"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68382-773-06)", "package_ndc": "68382-773-06", "marketing_start_date": "20170809"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (68382-773-10)", "package_ndc": "68382-773-10", "marketing_start_date": "20170809"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68382-773-16)", "package_ndc": "68382-773-16", "marketing_start_date": "20170809"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-773-77)  / 10 TABLET in 1 BLISTER PACK (68382-773-30)", "package_ndc": "68382-773-77", "marketing_start_date": "20170809"}], "brand_name": "ezetimibe", "product_id": "68382-773_ebb60f24-14be-4be0-b5e2-31e695eae876", "dosage_form": "TABLET", "pharm_class": ["Decreased Cholesterol Absorption [PE]", "Dietary Cholesterol Absorption Inhibitor [EPC]"], "product_ndc": "68382-773", "generic_name": "ezetimibe", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "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"}