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United States · US · US:68071-1964_1d4bf188-0fd0-b281-e063-6294a90a6ac3
Cetirizine Hydrochloride
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNuCare Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11680711964110 TABLET in 1 BOTTLE (68071-1964-1)
- ndc11680711964330 TABLET in 1 BOTTLE (68071-1964-3)
- ndc1168071196477 TABLET in 1 BOTTLE (68071-1964-7)
- ndc11680711964990 TABLET in 1 BOTTLE (68071-1964-9)
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A077829
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": "68071-1964_1d4bf188-0fd0-b281-e063-6294a90a6ac3",
"productndc": "68071-1964",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "077829",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG",
"product_no": "001",
"approval_date": "Aug 26, 2009"
},
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "002",
"approval_date": "Aug 26, 2009"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG",
"product_no": "003",
"approval_date": "Aug 26, 2009"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "004",
"approval_date": "Aug 26, 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": "ANDA077829",
"marketing_category": "ANDA",
"nonproprietary_name": "Cetirizine Hydrochloride",
"start_marketing_date": "20091001",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code R06AE.
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