cetirizine hydrochloride

Generic: cetirizine hydrochloride

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

Drug Facts

Product Profile

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

cetirizine hydrochloride 1 mg/mL

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 71205-435
Product ID 71205-435_faa9abcb-37ba-4e5c-8404-4e13b531febd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076601
Listing Expiration 2026-12-31
Marketing Start 2014-05-01

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 71205435
Hyphenated Format 71205-435

Supplemental Identifiers

RxCUI
1014673
UPC
0371205435042
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 ANDA076601 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (71205-435-04) / 120 mL in 1 BOTTLE
source: ndc

Packages (1)

71205-435-04 1 BOTTLE in 1 CARTON (71205-435-04) / 120 mL in 1 BOTTLE

Ingredients (1)

cetirizine hydrochloride (1 mg/mL)

Linked Drug Pages (1)

Cetirizine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "faa9abcb-37ba-4e5c-8404-4e13b531febd", "openfda": {"upc": ["0371205435042"], "unii": ["64O047KTOA"], "rxcui": ["1014673"], "spl_set_id": ["4ed61888-4b22-4e11-96e7-f70aa516db4f"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (71205-435-04)  / 120 mL in 1 BOTTLE", "package_ndc": "71205-435-04", "marketing_start_date": "20200319"}], "brand_name": "Cetirizine Hydrochloride", "product_id": "71205-435_faa9abcb-37ba-4e5c-8404-4e13b531febd", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "71205-435", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "1 mg/mL"}], "application_number": "ANDA076601", "marketing_category": "ANDA", "marketing_start_date": "20140501", "listing_expiration_date": "20261231"}