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United States · US · US:25000-220_cbb30ec0-aba7-4035-8f4a-a3e82b064857
Cetirizine Hydrochloride Tablets, 10 mg
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMARKSANS PHARMA LIMITED
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 5
- ndc1125000220031 BOTTLE in 1 CARTON (25000-220-03) / 30 TABLET in 1 BOTTLE
- ndc1125000220081 BOTTLE in 1 CARTON (25000-220-08) / 100 TABLET in 1 BOTTLE
- ndc1125000220141000 TABLET in 1 BOTTLE (25000-220-14)
- ndc1125000220781 BLISTER PACK in 1 CARTON (25000-220-78) / 7 TABLET in 1 BLISTER PACK
- ndc1125000220811 BLISTER PACK in 1 CARTON (25000-220-81) / 14 TABLET in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A078933
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": "25000-220_cbb30ec0-aba7-4035-8f4a-a3e82b064857",
"productndc": "25000-220",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "078933",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG",
"product_no": "001",
"approval_date": "Jun 15, 2010"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "002",
"approval_date": "Jun 15, 2010"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG",
"product_no": "003",
"approval_date": "Jun 15, 2010"
},
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "10MG",
"product_no": "004",
"approval_date": "Jun 15, 2010"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "CETIRIZINE HYDROCHLORIDE",
"proprietary_name": "Cetirizine Hydrochloride Tablets, 10 mg",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078933",
"marketing_category": "ANDA",
"nonproprietary_name": "Cetirizine Hydrochloride",
"start_marketing_date": "20220113",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code R06AE.
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