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United States · US · US:45802-147_1e179f00-1e00-4199-bf78-bb00aa268c74
Cetirizine hydrochloride and Pseudoephedrine hydrochloride
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPadagis Israel Pharmaceuticals Ltd
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11458021475312 BLISTER PACK in 1 CARTON (45802-147-53) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
- ndc11458021476224 BLISTER PACK in 1 CARTON (45802-147-62) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A210719
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": "45802-147_1e179f00-1e00-4199-bf78-bb00aa268c74",
"productndc": "45802-147",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "210719",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG;120MG",
"product_no": "001",
"approval_date": "Nov 16, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"proprietary_name": "Cetirizine hydrochloride and Pseudoephedrine hydrochloride",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA210719",
"marketing_category": "ANDA",
"nonproprietary_name": "Cetirizine hydrochloride, Pseudoephedrine hydrochloride",
"start_marketing_date": "20200331",
"active_numerator_strength": "5; 120"
}Related drugs
Other records sharing ATC code R06AE.
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