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United States · US · US:70752-104_eb119bad-6e21-4378-a556-41b1b790d84c
CETIRIZINE HYDROCHLORIDE
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerQUAGEN PHARMACEUTICALS LLC
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170752104061 BOTTLE, PLASTIC in 1 CARTON (70752-104-06) / 118 mL in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A212266
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": "70752-104_eb119bad-6e21-4378-a556-41b1b790d84c",
"productndc": "70752-104",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "212266",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG/5ML",
"product_no": "001",
"approval_date": "May 16, 2019"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "CETIRIZINE HYDROCHLORIDE",
"proprietary_name": "CETIRIZINE HYDROCHLORIDE",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA212266",
"marketing_category": "ANDA",
"nonproprietary_name": "CETIRIZINE HYDROCHLORIDE",
"start_marketing_date": "20221015",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code R06AE.
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