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United States · US · US:0363-6340_4d2c69cb-1f56-68a5-e063-6394a90a7074
Hives Relief
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerWALGREEN COMPANY
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11036363401330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0363-6340-13)
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": {
"4526b65c-b0e7-180c-e063-6394a90ae916": {
"match": "brand_token",
"title": "HIVES RELIEF (CETIRIZINE TABLETS) TABLET, FILM COATED [WALGREEN COMPANY]",
"spl_version": "2",
"published_date": "2026-03-20"
}
},
"productid": "0363-6340_4d2c69cb-1f56-68a5-e063-6394a90a7074",
"productndc": "0363-6340",
"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": "Hives Relief",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078862",
"marketing_category": "ANDA",
"nonproprietary_name": "Cetirizine Tablets",
"start_marketing_date": "20260320",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code R06AE.
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