cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: proficient rx lp
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler proficient rx lp
Dosage Form TABLET
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 10 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-164
Product ID 71205-164_0df97f57-2593-49af-83ca-138de55289c8
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA077829
Listing Expiration 2026-12-31
Marketing Start 2009-10-01

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 71205164
Hyphenated Format 71205-164

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 ANDA077829 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 15 TABLET in 1 BOTTLE (71205-164-15)
  • 30 TABLET in 1 BOTTLE (71205-164-30)
  • 60 TABLET in 1 BOTTLE (71205-164-60)
  • 90 TABLET in 1 BOTTLE (71205-164-90)
source: ndc

Packages (4)

71205-164-15 15 TABLET in 1 BOTTLE (71205-164-15) 71205-164-30 30 TABLET in 1 BOTTLE (71205-164-30) 71205-164-60 60 TABLET in 1 BOTTLE (71205-164-60) 71205-164-90 90 TABLET in 1 BOTTLE (71205-164-90)

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": "0df97f57-2593-49af-83ca-138de55289c8", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014678"], "spl_set_id": ["0b116de8-55c5-44dc-b0b6-f5a919e39a65"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET in 1 BOTTLE (71205-164-15)", "package_ndc": "71205-164-15", "marketing_start_date": "20181201"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (71205-164-30)", "package_ndc": "71205-164-30", "marketing_start_date": "20181201"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71205-164-60)", "package_ndc": "71205-164-60", "marketing_start_date": "20181201"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71205-164-90)", "package_ndc": "71205-164-90", "marketing_start_date": "20181201"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "71205-164_0df97f57-2593-49af-83ca-138de55289c8", "dosage_form": "TABLET", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "71205-164", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA077829", "marketing_category": "ANDA", "marketing_start_date": "20091001", "listing_expiration_date": "20261231"}