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United States · US · US:62135-057_06fce480-76eb-a204-e063-6394a90a3bbc
Cetirizine Hydrochloride Oral Solution
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerChartwell RX, LLC
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116213505741120 mL in 1 BOTTLE (62135-057-41)
- ndc116213505747473 mL in 1 BOTTLE (62135-057-47)
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A078876
AA
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": {
"817d07cf-5e31-421f-9e95-943bae01f5b0": {
"match": "brand_token",
"title": "CETIRIZINE HYDROCHLORIDE TABLET, CHEWABLE [SANDOZ INC]",
"spl_version": "8",
"published_date": "2026-06-01"
}
},
"productid": "62135-057_06fce480-76eb-a204-e063-6394a90a3bbc",
"productndc": "62135-057",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "078876",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "5MG/5ML",
"product_no": "001",
"approval_date": "May 11, 2012"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CETIRIZINE HYDROCHLORIDE",
"proprietary_name": "Cetirizine Hydrochloride Oral Solution",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA078876",
"marketing_category": "ANDA",
"nonproprietary_name": "Cetirizine Hydrochloride Oral Solution",
"start_marketing_date": "20120511",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code R06AE.
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