childrens cetirizine hydrochloride

Generic: cetirizine hydrochloride

Labeler: chain drug consortium, llc (premier value)
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name childrens cetirizine hydrochloride
Generic Name cetirizine hydrochloride
Labeler chain drug consortium, llc (premier value)
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 5 mg/5mL

Manufacturer
Chain Drug Consortium, LLC (Premier Value)

Identifiers & Regulatory

Product NDC 68016-023
Product ID 68016-023_c067a0f7-cadb-42cb-9bd4-6b901aec98c4
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA090182
Listing Expiration 2026-12-31
Marketing Start 2008-04-22

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 68016023
Hyphenated Format 68016-023

Supplemental Identifiers

RxCUI
1014673
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 childrens cetirizine hydrochloride (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 (68016-023-43) / 120 mL in 1 BOTTLE
source: ndc

Packages (1)

68016-023-43 1 BOTTLE in 1 CARTON (68016-023-43) / 120 mL in 1 BOTTLE

Ingredients (1)

cetirizine hydrochloride (5 mg/5mL)

Linked Drug Pages (1)

Childrens Cetirizine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c067a0f7-cadb-42cb-9bd4-6b901aec98c4", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014673"], "spl_set_id": ["b47b0c8b-59d5-4e17-95be-a992c6861ee7"], "manufacturer_name": ["Chain Drug Consortium, LLC (Premier Value)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68016-023-43)  / 120 mL in 1 BOTTLE", "package_ndc": "68016-023-43", "marketing_start_date": "20080422"}], "brand_name": "Childrens Cetirizine Hydrochloride", "product_id": "68016-023_c067a0f7-cadb-42cb-9bd4-6b901aec98c4", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68016-023", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Chain Drug Consortium, LLC (Premier Value)", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens Cetirizine Hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "ANDA090182", "marketing_category": "ANDA", "marketing_start_date": "20080422", "listing_expiration_date": "20261231"}