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United States · US · US:10267-3579_3633ac85-4814-e6a7-e063-6294a90a375d
Cetirizine Hydrochloride 10 mg
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerContract Pharmacal Corp.
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc1110267357911 BOTTLE in 1 CARTON (10267-3579-1) / 100 TABLET, FILM COATED in 1 BOTTLE
- ndc1110267357931 BOTTLE in 1 CARTON (10267-3579-3) / 30 TABLET, FILM COATED in 1 BOTTLE
- ndc111026735794100 TABLET, FILM COATED in 1 BOTTLE (10267-3579-4)
- ndc111026735796365 TABLET, FILM COATED in 1 BOTTLE (10267-3579-6)
- ndc1110267357971 BOTTLE in 1 CARTON (10267-3579-7) / 60 TABLET, FILM COATED in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A076047
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": "10267-3579_3633ac85-4814-e6a7-e063-6294a90a375d",
"productndc": "10267-3579",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "076047",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG",
"product_no": "001",
"approval_date": "Dec 27, 2007"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "002",
"approval_date": "Dec 27, 2007"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "CETIRIZINE HYDROCHLORIDE",
"proprietary_name": "Cetirizine Hydrochloride 10 mg",
"active_ingred_unit": "mg/1",
"application_number": "ANDA076047",
"marketing_category": "ANDA",
"nonproprietary_name": "Cetirizine Hydrochloride 10 mg",
"start_marketing_date": "20250416",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code R06AE.
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