childrens cetirzine

Generic: cetirizine hydrochloride

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

Drug Facts

Product Profile

Brand Name childrens cetirzine
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 68016-106
Product ID 68016-106_51b02412-ebbd-4045-8af4-4b8b8e90daf4
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA201546
Listing Expiration 2026-12-31
Marketing Start 2011-05-20

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 68016106
Hyphenated Format 68016-106

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 cetirzine (source: ndc)
Generic Name cetirizine hydrochloride (source: ndc)
Application Number ANDA201546 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (68016-106-08) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

68016-106-08 1 BOTTLE in 1 CARTON (68016-106-08) / 118 mL in 1 BOTTLE

Ingredients (1)

cetirizine hydrochloride (5 mg/5mL)

Linked Drug Pages (1)

Childrens Cetirzine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "51b02412-ebbd-4045-8af4-4b8b8e90daf4", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014673"], "spl_set_id": ["6b22f568-7ebd-4479-b764-6e5481d8c15a"], "manufacturer_name": ["Pharmacy Value Alliance LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (68016-106-08)  / 118 mL in 1 BOTTLE", "package_ndc": "68016-106-08", "marketing_start_date": "20110520"}], "brand_name": "Childrens Cetirzine", "product_id": "68016-106_51b02412-ebbd-4045-8af4-4b8b8e90daf4", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "68016-106", "generic_name": "Cetirizine Hydrochloride", "labeler_name": "Pharmacy Value Alliance LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens", "brand_name_suffix": "Cetirzine", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "ANDA201546", "marketing_category": "ANDA", "marketing_start_date": "20110520", "listing_expiration_date": "20261231"}