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United States · US · US:85766-149_4a23b37b-a8da-30d2-e063-6294a90ab21f
Cetirizine Hydrochloride
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerSportpharm LLC
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 6
- ndc118576614901100 TABLET in 1 BOTTLE (85766-149-01)
- ndc118576614905500 TABLET in 1 BOTTLE (85766-149-05)
- ndc11857661491010 TABLET in 1 BOTTLE (85766-149-10)
- ndc11857661493030 TABLET in 1 BOTTLE (85766-149-30)
- ndc11857661496060 TABLET in 1 BOTTLE (85766-149-60)
- ndc11857661499090 TABLET in 1 BOTTLE (85766-149-90)
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A077829
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": "85766-149_4a23b37b-a8da-30d2-e063-6294a90ab21f",
"productndc": "85766-149",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "077829",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG",
"product_no": "001",
"approval_date": "Aug 26, 2009"
},
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "002",
"approval_date": "Aug 26, 2009"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG",
"product_no": "003",
"approval_date": "Aug 26, 2009"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "004",
"approval_date": "Aug 26, 2009"
}
],
"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": "ANDA077829",
"marketing_category": "ANDA",
"nonproprietary_name": "Cetirizine Hydrochloride",
"start_marketing_date": "20091001",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code R06AE.
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