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United States · US · US:50580-719_4ec5aa70-7743-2cf9-e063-6394a90a06dd
ZYRTEC-D
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerKenvue Brands LLC
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1150580719122 BLISTER PACK in 1 CARTON (50580-719-12) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1150580719244 BLISTER PACK in 1 CARTON (50580-719-24) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
N021150
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": {
"f1ecf9ba-1c03-7fb7-e053-2a95a90a875a": {
"match": "brand_token",
"title": "ZYRTEC-D (CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [KENVUE BRANDS LLC]",
"spl_version": "6",
"published_date": "2026-04-15"
}
},
"productid": "50580-719_4ec5aa70-7743-2cf9-e063-6394a90a06dd",
"productndc": "50580-719",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "021150",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "5MG;120MG",
"product_no": "002",
"approval_date": "Nov 9, 2007"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"proprietary_name": "ZYRTEC-D",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA021150",
"marketing_category": "NDA",
"nonproprietary_name": "Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride",
"start_marketing_date": "20230228",
"active_numerator_strength": "5; 120"
}Related drugs
Other records sharing ATC code R06AE.
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