premier value childrens cetirizine

Generic: cetirizine hydrochloride

Labeler: pharmacy value alliance llc
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name premier value childrens cetirizine
Generic Name cetirizine hydrochloride
Labeler pharmacy value alliance llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 5 mg/5mL

Manufacturer
Pharmacy Value Alliance LLC

Identifiers & Regulatory

Product NDC 68016-165
Product ID 68016-165_39ad746e-1dd7-f3fb-e063-6394a90a767d
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA090182
Listing Expiration 2026-12-31
Marketing Start 2011-09-08

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 68016165
Hyphenated Format 68016-165

Supplemental Identifiers

RxCUI
1014673
UPC
0840986028632
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 premier value childrens cetirizine (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA090182 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68016-165-00) / 120 mL in 1 BOTTLE
source: ndc

Packages (1)

68016-165-00 1 BOTTLE in 1 CARTON (68016-165-00) / 120 mL in 1 BOTTLE

Ingredients (1)

cetirizine hydrochloride (5 mg/5mL)

Linked Drug Pages (1)

Premier Value Childrens Cetirizine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "39ad746e-1dd7-f3fb-e063-6394a90a767d", "openfda": {"upc": ["0840986028632"], "unii": ["64O047KTOA"], "rxcui": ["1014673"], "spl_set_id": ["a4931f0b-86f2-42c5-b2df-b359bb46f44a"], "manufacturer_name": ["Pharmacy Value Alliance LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68016-165-00)  / 120 mL in 1 BOTTLE", "package_ndc": "68016-165-00", "marketing_start_date": "20110908"}], "brand_name": "Premier Value Childrens Cetirizine", "product_id": "68016-165_39ad746e-1dd7-f3fb-e063-6394a90a767d", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68016-165", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Pharmacy Value Alliance LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Premier Value", "brand_name_suffix": "Childrens Cetirizine", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "ANDA090182", "marketing_category": "ANDA", "marketing_start_date": "20110908", "listing_expiration_date": "20261231"}