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United States · US · US:71205-207_517ed467-a0d0-43ab-99ce-e6a4808800c4
cetirizine hydrochloride
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc1171205207066 TABLET in 1 BOTTLE (71205-207-06)
- ndc11712052071010 TABLET in 1 BOTTLE (71205-207-10)
- ndc11712052071515 TABLET in 1 BOTTLE (71205-207-15)
- ndc11712052073030 TABLET in 1 BOTTLE (71205-207-30)
- ndc11712052076060 TABLET in 1 BOTTLE (71205-207-60)
- ndc11712052079090 TABLET in 1 BOTTLE (71205-207-90)
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A078336
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": "71205-207_517ed467-a0d0-43ab-99ce-e6a4808800c4",
"productndc": "71205-207",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "078336",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG",
"product_no": "001",
"approval_date": "Dec 27, 2007"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "002",
"approval_date": "Dec 27, 2007"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG",
"product_no": "003",
"approval_date": "Dec 27, 2007"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "004",
"approval_date": "Dec 27, 2007"
}
],
"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": "ANDA078336",
"marketing_category": "ANDA",
"nonproprietary_name": "Cetirizine Hydrochloride",
"start_marketing_date": "20071227",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code R06AE.
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