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United States · US · US:70677-1279_2e9de837-00b0-491d-a2e3-766fab46380a
Cetirizine HCl
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerStrategic Sourcing Services LLC
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc1170677127911 BOTTLE in 1 CARTON (70677-1279-1) / 14 TABLET in 1 BOTTLE
- ndc1170677127921 BOTTLE in 1 CARTON (70677-1279-2) / 30 TABLET in 1 BOTTLE
- ndc1170677127931 BOTTLE in 1 CARTON (70677-1279-3) / 60 TABLET in 1 BOTTLE
- ndc1170677127941 BOTTLE in 1 CARTON (70677-1279-4) / 90 TABLET in 1 BOTTLE
- ndc1170677127951 BOTTLE in 1 CARTON (70677-1279-5) / 300 TABLET in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A078427
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": "70677-1279_2e9de837-00b0-491d-a2e3-766fab46380a",
"productndc": "70677-1279",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "078427",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG",
"product_no": "003",
"approval_date": "Dec 28, 2007"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "004",
"approval_date": "Dec 28, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "CETIRIZINE HYDROCHLORIDE",
"proprietary_name": "Cetirizine HCl",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078427",
"marketing_category": "ANDA",
"nonproprietary_name": "Cetirizine",
"start_marketing_date": "20250301",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code R06AE.
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