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United States · US · US:70720-100_32f69271-f228-41a9-8133-61cb47d73045
QUZYTTIR
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTerSera Therapeutics LLC
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1170720100101 VIAL, GLASS in 1 CARTON (70720-100-10) / 1 mL in 1 VIAL, GLASS (70720-100-01)
- ndc11707201002525 VIAL, GLASS in 1 CARTON (70720-100-25) / 1 mL in 1 VIAL, GLASS (70720-100-01)
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
N211415
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": "INTRAVENOUS",
"spl_meta": {
"f33e859d-ebc9-4d4f-a57d-204c48760d20": {
"match": "brand_token",
"title": "QUZYTTIR (CETIRIZINE HYDROCHLORIDE) INJECTION [TERSERA THERAPEUTICS LLC]",
"spl_version": "8",
"published_date": "2026-03-11"
}
},
"productid": "70720-100_32f69271-f228-41a9-8133-61cb47d73045",
"productndc": "70720-100",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "211415",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "10MG/ML (10MG/ML)",
"product_no": "001",
"approval_date": "Oct 4, 2019"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CETIRIZINE HYDROCHLORIDE",
"proprietary_name": "QUZYTTIR",
"active_ingred_unit": "mg/mL",
"application_number": "NDA211415",
"marketing_category": "NDA",
"nonproprietary_name": "Cetirizine Hydrochloride",
"start_marketing_date": "20191113",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code R06AE.
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