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United States · US · US:62207-764_2432f862-6d80-666d-e063-6294a90acf74
Cetirizine hydrochloride
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerGranules India Ltd
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1162207764491000 TABLET, COATED in 1 BOTTLE (62207-764-49)
- ndc11622077645514 TABLET, COATED in 1 BOTTLE (62207-764-55)
- ndc11622077647313 BLISTER PACK in 1 CARTON (62207-764-73) / 10 TABLET, COATED in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A209274
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": "62207-764_2432f862-6d80-666d-e063-6294a90acf74",
"productndc": "62207-764",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "209274",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "001",
"approval_date": "Dec 22, 2017"
}
],
"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": "ANDA209274",
"marketing_category": "ANDA",
"nonproprietary_name": "Cetirizine hydrochloride",
"start_marketing_date": "20180528",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code R06AE.
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