cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: mylan institutional inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler mylan institutional inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Mylan Institutional Inc.

Identifiers & Regulatory

Product NDC 51079-597
Product ID 51079-597_3a39c300-d753-6884-e063-6394a90aa53e
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA076677
Listing Expiration 2026-12-31
Marketing Start 2012-03-30

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 51079597
Hyphenated Format 51079-597

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 hydrochloride (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA076677 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-597-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-597-01)
source: ndc

Packages (1)

51079-597-20 100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-597-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-597-01)

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Cetirizine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3a39c300-d753-6884-e063-6394a90aa53e", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["bd0dc7f6-5fb9-4381-bd81-b150b75a2c68"], "manufacturer_name": ["Mylan Institutional Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (51079-597-20)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-597-01)", "package_ndc": "51079-597-20", "marketing_start_date": "20120330"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "51079-597_3a39c300-d753-6884-e063-6394a90aa53e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "51079-597", "generic_name": "cetirizine hydrochloride", "labeler_name": "Mylan Institutional Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA076677", "marketing_category": "ANDA", "marketing_start_date": "20120330", "listing_expiration_date": "20261231"}