cetirizine hydrochloride (allergy)

Generic: cetirizine hydrochloride

Labeler: walgreen co.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride (allergy)
Generic Name cetirizine hydrochloride
Labeler walgreen co.
Dosage Form CAPSULE
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
WALGREEN CO.

Identifiers & Regulatory

Product NDC 0363-0068
Product ID 0363-0068_5d00aeb2-1ed9-4d51-a939-e137af4608f2
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA209107
Listing Expiration 2026-12-31
Marketing Start 2020-06-08

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 03630068
Hyphenated Format 0363-0068

Supplemental Identifiers

RxCUI
1014675
UNII
64O047KTOA

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 cetirizine hydrochloride (allergy) (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA209107 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0363-0068-12) / 40 CAPSULE in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0363-0068-53) / 25 CAPSULE in 1 BOTTLE
source: ndc

Packages (2)

0363-0068-12 1 BOTTLE in 1 CARTON (0363-0068-12) / 40 CAPSULE in 1 BOTTLE 0363-0068-53 1 BOTTLE in 1 CARTON (0363-0068-53) / 25 CAPSULE in 1 BOTTLE

Ingredients (1)

cetirizine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Cetirizine Hydrochloride (Allergy) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "5d00aeb2-1ed9-4d51-a939-e137af4608f2", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014675"], "spl_set_id": ["3d2eac7f-db44-4771-8c7e-a38e68a7f24b"], "manufacturer_name": ["WALGREEN CO."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0363-0068-12)  / 40 CAPSULE in 1 BOTTLE", "package_ndc": "0363-0068-12", "marketing_start_date": "20200608"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0363-0068-53)  / 25 CAPSULE in 1 BOTTLE", "package_ndc": "0363-0068-53", "marketing_start_date": "20200608"}], "brand_name": "Cetirizine Hydrochloride (Allergy)", "product_id": "0363-0068_5d00aeb2-1ed9-4d51-a939-e137af4608f2", "dosage_form": "CAPSULE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0363-0068", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "WALGREEN CO.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride (Allergy)", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA209107", "marketing_category": "ANDA", "marketing_start_date": "20200608", "listing_expiration_date": "20261231"}