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United States · US · US:10135-762_3f7dc523-2934-780a-e063-6294a90a837f
Cetirizine Hydrochloride
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMarlex Pharmaceuticals, Inc
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc111013576201100 TABLET in 1 BOTTLE (10135-762-01)
- ndc111013576203300 TABLET in 1 BOTTLE (10135-762-03)
- ndc111013576205500 TABLET in 1 BOTTLE (10135-762-05)
- ndc11101357623030 TABLET in 1 BOTTLE (10135-762-30)
- ndc11101357629090 TABLET in 1 BOTTLE (10135-762-90)
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A077498
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": "10135-762_3f7dc523-2934-780a-e063-6294a90a837f",
"productndc": "10135-762",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "077498",
"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"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG",
"product_no": "003",
"approval_date": "Dec 27, 2007"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "004",
"approval_date": "Dec 27, 2007"
}
],
"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": "ANDA077498",
"marketing_category": "ANDA",
"nonproprietary_name": "Cetirizine Hydrochloride",
"start_marketing_date": "20221001",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code R06AE.
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