ezetimibe

Generic: ezetimibe

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ezetimibe
Generic Name ezetimibe
Labeler camber pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

ezetimibe 10 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-628
Product ID 31722-628_1d93c66e-c5ea-de6f-e063-6294a90acfb8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210859
Listing Expiration 2026-12-31
Marketing Start 2022-07-26

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 31722628
Hyphenated Format 31722-628

Supplemental Identifiers

RxCUI
349556
UPC
0331722628051 0331722628303 0331722628907
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 ANDA210859 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (31722-628-01)
  • 500 TABLET in 1 BOTTLE (31722-628-05)
  • 1000 TABLET in 1 BOTTLE (31722-628-10)
  • 30 TABLET in 1 BOTTLE (31722-628-30)
  • 100 BLISTER PACK in 1 CARTON (31722-628-31) / 10 TABLET in 1 BLISTER PACK
  • 100 BLISTER PACK in 1 CARTON (31722-628-34) / 10 TABLET in 1 BLISTER PACK
  • 90 TABLET in 1 BOTTLE (31722-628-90)
source: ndc

Packages (7)

31722-628-01 100 TABLET in 1 BOTTLE (31722-628-01) 31722-628-05 500 TABLET in 1 BOTTLE (31722-628-05) 31722-628-10 1000 TABLET in 1 BOTTLE (31722-628-10) 31722-628-30 30 TABLET in 1 BOTTLE (31722-628-30) 31722-628-31 100 BLISTER PACK in 1 CARTON (31722-628-31) / 10 TABLET in 1 BLISTER PACK 31722-628-34 100 BLISTER PACK in 1 CARTON (31722-628-34) / 10 TABLET in 1 BLISTER PACK 31722-628-90 90 TABLET in 1 BOTTLE (31722-628-90)

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": "1d93c66e-c5ea-de6f-e063-6294a90acfb8", "openfda": {"nui": ["N0000008553", "N0000175911"], "upc": ["0331722628051", "0331722628303", "0331722628907"], "unii": ["EOR26LQQ24"], "rxcui": ["349556"], "spl_set_id": ["c07fe2e0-dad4-48b5-8a07-7d57a4035ccd"], "pharm_class_pe": ["Decreased Cholesterol Absorption [PE]"], "pharm_class_epc": ["Dietary Cholesterol Absorption Inhibitor [EPC]"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (31722-628-01)", "package_ndc": "31722-628-01", "marketing_start_date": "20220726"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (31722-628-05)", "package_ndc": "31722-628-05", "marketing_start_date": "20230925"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (31722-628-10)", "package_ndc": "31722-628-10", "marketing_start_date": "20230925"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (31722-628-30)", "package_ndc": "31722-628-30", "marketing_start_date": "20220726"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (31722-628-31)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "31722-628-31", "marketing_start_date": "20220726"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (31722-628-34)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "31722-628-34", "marketing_start_date": "20220726"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (31722-628-90)", "package_ndc": "31722-628-90", "marketing_start_date": "20220726"}], "brand_name": "EZETIMIBE", "product_id": "31722-628_1d93c66e-c5ea-de6f-e063-6294a90acfb8", "dosage_form": "TABLET", "pharm_class": ["Decreased Cholesterol Absorption [PE]", "Dietary Cholesterol Absorption Inhibitor [EPC]"], "product_ndc": "31722-628", "generic_name": "EZETIMIBE", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "EZETIMIBE", "active_ingredients": [{"name": "EZETIMIBE", "strength": "10 mg/1"}], "application_number": "ANDA210859", "marketing_category": "ANDA", "marketing_start_date": "20220726", "listing_expiration_date": "20261231"}