childrens cetirizine hydrochloride

Generic: cetirizine hcl

Labeler: major pharmaceuticals
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name childrens cetirizine hydrochloride
Generic Name cetirizine hcl
Labeler major pharmaceuticals
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

cetirizine hydrochloride 5 mg/5mL

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6765
Product ID 0904-6765_5f4ad745-20b6-4ed5-81aa-448c658d57c2
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA204226
Listing Expiration 2027-12-31
Marketing Start 2018-08-22

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 09046765
Hyphenated Format 0904-6765

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 hcl (source: ndc)
Application Number ANDA204226 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (0904-6765-20) / 118 mL in 1 BOTTLE
source: ndc

Packages (1)

0904-6765-20 1 BOTTLE in 1 CARTON (0904-6765-20) / 118 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": "5f4ad745-20b6-4ed5-81aa-448c658d57c2", "openfda": {"unii": ["64O047KTOA"], "rxcui": ["1014673"], "spl_set_id": ["db297aa4-4384-48f2-b2bd-c842efc8a844"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (0904-6765-20)  / 118 mL in 1 BOTTLE", "package_ndc": "0904-6765-20", "marketing_start_date": "20180822"}], "brand_name": "childrens cetirizine hydrochloride", "product_id": "0904-6765_5f4ad745-20b6-4ed5-81aa-448c658d57c2", "dosage_form": "SOLUTION", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]"], "product_ndc": "0904-6765", "generic_name": "Cetirizine HCl", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN OTC DRUG", "brand_name_base": "childrens cetirizine hydrochloride", "active_ingredients": [{"name": "CETIRIZINE HYDROCHLORIDE", "strength": "5 mg/5mL"}], "application_number": "ANDA204226", "marketing_category": "ANDA", "marketing_start_date": "20180822", "listing_expiration_date": "20271231"}