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United States · US · US:58602-808_30494d65-a846-4f13-a076-242f193e4651
Cetirizine Hydrochloride (Hives Relief)
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerAurohealth LLC
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc1158602808041 BOTTLE in 1 CARTON (58602-808-04) / 12 CAPSULE in 1 BOTTLE
- ndc1158602808121 BOTTLE in 1 CARTON (58602-808-12) / 40 CAPSULE in 1 BOTTLE
- ndc11586028081665 BOTTLE in 1 CARTON (58602-808-16) / 65 CAPSULE in 1 BOTTLE
- ndc1158602808531 BOTTLE in 1 CARTON (58602-808-53) / 25 CAPSULE in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A209107
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": "58602-808_30494d65-a846-4f13-a076-242f193e4651",
"productndc": "58602-808",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "209107",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "001",
"approval_date": "Jul 20, 2018"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "002",
"approval_date": "Jul 20, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "CETIRIZINE HYDROCHLORIDE",
"proprietary_name": "Cetirizine Hydrochloride (Hives Relief)",
"active_ingred_unit": "mg/1",
"application_number": "ANDA209107",
"marketing_category": "ANDA",
"nonproprietary_name": "Cetirizine Hydrochloride",
"start_marketing_date": "20180720",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code R06AE.
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