cetirizine

Generic: cetirizine hydrochloride

Labeler: northwind health company, llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine
Generic Name cetirizine hydrochloride
Labeler northwind health company, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 51655-194
Product ID 51655-194_48c43399-eff4-c940-e063-6394a90aacd9
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA078336
Listing Expiration 2027-12-31
Marketing Start 2022-10-18

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51655194
Hyphenated Format 51655-194

Supplemental Identifiers

RxCUI
1014678
UNII
64O047KTOA

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 cetirizine (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA078336 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-194-26)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-194-52)
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-194-60)
source: ndc

Packages (3)

51655-194-26 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-194-26) 51655-194-52 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-194-52) 51655-194-60 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-194-60)

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Cetirizine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "48c43399-eff4-c940-e063-6394a90aacd9", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["f2b4d221-30ae-5a43-e053-2995a90a238a"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-194-26)", "package_ndc": "51655-194-26", "marketing_start_date": "20221115"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-194-52)", "package_ndc": "51655-194-52", "marketing_start_date": "20230302"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-194-60)", "package_ndc": "51655-194-60", "marketing_start_date": "20221018"}], "brand_name": "Cetirizine", "product_id": "51655-194_48c43399-eff4-c940-e063-6394a90aacd9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "51655-194", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Northwind Health Company, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA078336", "marketing_category": "ANDA", "marketing_start_date": "20221018", "listing_expiration_date": "20271231"}