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United States · US · US:68016-023_c067a0f7-cadb-42cb-9bd4-6b901aec98c4
Childrens Cetirizine Hydrochloride
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerChain Drug Consortium, LLC (Premier Value)
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168016023431 BOTTLE in 1 CARTON (68016-023-43) / 120 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A090182
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "64O047KTOA",
"rxcui": "203150",
"inchikey": "PGLIUCLTXOYQMV-UHFFFAOYSA-N",
"display_name": "CETIRIZINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"436c0126-4ff3-c082-e063-6294a90a3d72": {
"match": "brand_token",
"title": "CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [KESIN PHARMA CORPORATION]",
"spl_version": "2",
"published_date": "2026-06-01"
}
},
"productid": "68016-023_c067a0f7-cadb-42cb-9bd4-6b901aec98c4",
"productndc": "68016-023",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "090182",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG/5ML",
"product_no": "001",
"approval_date": "Apr 22, 2008"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG/5ML",
"product_no": "002",
"approval_date": "Apr 22, 2008"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "CETIRIZINE HYDROCHLORIDE",
"proprietary_name": "Childrens Cetirizine Hydrochloride",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA090182",
"marketing_category": "ANDA",
"nonproprietary_name": "Cetirizine Hydrochloride",
"start_marketing_date": "20080422",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code R06AE.
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