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United States · US · US:69452-465_45745bf3-a132-b51a-e063-6394a90a712e
CETIRIZINE HYDROCHLORIDE
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBionpharma Inc.
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116945246581400 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-465-81)
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A078862
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": "69452-465_45745bf3-a132-b51a-e063-6394a90a712e",
"productndc": "69452-465",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "078862",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG",
"product_no": "001",
"approval_date": "Feb 19, 2009"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "002",
"approval_date": "Feb 19, 2009"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG",
"product_no": "003",
"approval_date": "Feb 19, 2009"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "004",
"approval_date": "Feb 19, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "CETIRIZINE HYDROCHLORIDE",
"proprietary_name": "CETIRIZINE HYDROCHLORIDE",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078862",
"marketing_category": "ANDA",
"nonproprietary_name": "CETIRIZINE HYDROCHLORIDE",
"start_marketing_date": "20241020",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code R06AE.
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