cetirizine hydrochloride (allergy)

Generic: cetirizine hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride (allergy)
Generic Name cetirizine hydrochloride
Labeler a-s medication solutions
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-6168
Product ID 50090-6168_3f1dc2f9-4fb5-40a4-828f-205ce8ee8d16
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA090760
Listing Expiration 2027-12-31
Marketing Start 2015-08-05

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 500906168
Hyphenated Format 50090-6168

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 (allergy) (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA090760 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (50090-6168-1)
  • 90 TABLET in 1 BOTTLE (50090-6168-3)
source: ndc

Packages (2)

50090-6168-1 30 TABLET in 1 BOTTLE (50090-6168-1) 50090-6168-3 90 TABLET in 1 BOTTLE (50090-6168-3)

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": "3f1dc2f9-4fb5-40a4-828f-205ce8ee8d16", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["158d3bcc-6a7f-4ee7-b181-be3fd6f94f8d"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (50090-6168-1)", "package_ndc": "50090-6168-1", "marketing_start_date": "20221026"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (50090-6168-3)", "package_ndc": "50090-6168-3", "marketing_start_date": "20230802"}], "brand_name": "Cetirizine Hydrochloride (Allergy)", "product_id": "50090-6168_3f1dc2f9-4fb5-40a4-828f-205ce8ee8d16", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "50090-6168", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride (Allergy)", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA090760", "marketing_category": "ANDA", "marketing_start_date": "20150805", "listing_expiration_date": "20271231"}