ezetimibe

Generic: ezetimibe

Labeler: northstar rx llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ezetimibe
Generic Name ezetimibe
Labeler northstar rx llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ezetimibe 10 mg/1

Manufacturer
NorthStar Rx LLC

Identifiers & Regulatory

Product NDC 16714-813
Product ID 16714-813_ce024e9f-19a7-4819-8069-60121c4cf6c4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209838
Listing Expiration 2026-12-31
Marketing Start 2021-02-01

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 16714813
Hyphenated Format 16714-813

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 ANDA209838 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (16714-813-01)
  • 90 TABLET in 1 BOTTLE (16714-813-02)
  • 500 TABLET in 1 BOTTLE (16714-813-03)
source: ndc

Packages (3)

16714-813-01 30 TABLET in 1 BOTTLE (16714-813-01) 16714-813-02 90 TABLET in 1 BOTTLE (16714-813-02) 16714-813-03 500 TABLET in 1 BOTTLE (16714-813-03)

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": "ce024e9f-19a7-4819-8069-60121c4cf6c4", "openfda": {"nui": ["N0000008553", "N0000175911"], "unii": ["EOR26LQQ24"], "rxcui": ["349556"], "spl_set_id": ["5f5644a9-e019-4e5d-ab6f-3d30b1024c5a"], "pharm_class_pe": ["Decreased Cholesterol Absorption [PE]"], "pharm_class_epc": ["Dietary Cholesterol Absorption Inhibitor [EPC]"], "manufacturer_name": ["NorthStar Rx LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (16714-813-01)", "package_ndc": "16714-813-01", "marketing_start_date": "20210201"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (16714-813-02)", "package_ndc": "16714-813-02", "marketing_start_date": "20210201"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (16714-813-03)", "package_ndc": "16714-813-03", "marketing_start_date": "20210201"}], "brand_name": "Ezetimibe", "product_id": "16714-813_ce024e9f-19a7-4819-8069-60121c4cf6c4", "dosage_form": "TABLET", "pharm_class": ["Decreased Cholesterol Absorption [PE]", "Dietary Cholesterol Absorption Inhibitor [EPC]"], "product_ndc": "16714-813", "generic_name": "Ezetimibe", "labeler_name": "NorthStar Rx LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ezetimibe", "active_ingredients": [{"name": "EZETIMIBE", "strength": "10 mg/1"}], "application_number": "ANDA209838", "marketing_category": "ANDA", "marketing_start_date": "20210201", "listing_expiration_date": "20261231"}