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United States · US · US:53943-519_5c71a4a6-cf88-4fdc-db4f-23235af0306b
Cetirizine Hydrochloride
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDiscount Drug Mart, Inc
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1153943519301 BOTTLE in 1 CARTON (53943-519-30) / 30 TABLET, FILM COATED in 1 BOTTLE
- ndc1153943519451 BOTTLE in 1 CARTON (53943-519-45) / 45 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A078343
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": "53943-519_5c71a4a6-cf88-4fdc-db4f-23235af0306b",
"productndc": "53943-519",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "078343",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG",
"product_no": "001",
"approval_date": "Jan 15, 2008"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "002",
"approval_date": "Jan 15, 2008"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "003",
"approval_date": "Jan 15, 2008"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG",
"product_no": "004",
"approval_date": "Jan 15, 2008"
}
],
"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": "ANDA078343",
"marketing_category": "ANDA",
"nonproprietary_name": "Cetirizine Hydrochloride",
"start_marketing_date": "20200120",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code R06AE.
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