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United States · US · US:61037-479_3b5908fd-b2c0-ba45-e063-6294a90a6fb0
CETIRIZINE HYDROCHLORIDE
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBAJAJ MEDICAL, LLC
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc116103747904240 mL in 1 BOTTLE, PLASTIC (61037-479-04)
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A090191
AA
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": "61037-479_3b5908fd-b2c0-ba45-e063-6294a90a6fb0",
"productndc": "61037-479",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "090191",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AA",
"strength": "5MG/5ML",
"product_no": "001",
"approval_date": "Nov 12, 2009"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CETIRIZINE HYDROCHLORIDE",
"proprietary_name": "CETIRIZINE HYDROCHLORIDE",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA090191",
"marketing_category": "ANDA",
"nonproprietary_name": "CETIRIZINE HYDROCHLORIDE",
"start_marketing_date": "20230912",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code R06AE.
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