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United States · US · US:36800-542_27895955-45c0-4a92-e063-6394a90a01cf
Cetirizine HCl
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerTOP CARE (Topco Associates LLC)
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1136800542151 BOTTLE, PLASTIC in 1 PACKAGE (36800-542-15) / 40 CAPSULE in 1 BOTTLE, PLASTIC
- ndc1136800542861 BOTTLE, PLASTIC in 1 PACKAGE (36800-542-86) / 25 CAPSULE in 1 BOTTLE, PLASTIC
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
N022429
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": "36800-542_27895955-45c0-4a92-e063-6394a90a01cf",
"productndc": "36800-542",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "022429",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "5MG",
"product_no": "001",
"approval_date": "Jul 23, 2009"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "10MG",
"product_no": "002",
"approval_date": "Jul 23, 2009"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "5MG",
"product_no": "003",
"approval_date": "Jul 23, 2009"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "10MG",
"product_no": "004",
"approval_date": "Jul 23, 2009"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "CETIRIZINE HYDROCHLORIDE",
"proprietary_name": "Cetirizine HCl",
"active_ingred_unit": "mg/1",
"application_number": "NDA022429",
"marketing_category": "NDA",
"nonproprietary_name": "Cetirizine HCl",
"start_marketing_date": "20241122",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code R06AE.
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