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United States · US · US:85786-203_48d835d7-5c9a-0bd6-e063-6394a90a61ba
Dr Simi Cetirizine Hydrochloride 10 mg
Orange BookUNIISPLATC R06AE
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerFarmacias De Similares TX LLC
CountryUS (United States)
ATC codeR06AE
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11857862033030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85786-203-30)
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": {
"8abd6d8e-c69e-4374-ace8-d42b2d3e171e": {
"match": "brand_token",
"title": "DR SCHOLLS FUNGAL NAIL CLEAR AND CURE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) LIQUID [SCHOLL'S WELLNESS COMPANY LLC]",
"spl_version": "4",
"published_date": "2026-05-20"
}
},
"productid": "85786-203_48d835d7-5c9a-0bd6-e063-6394a90a61ba",
"productndc": "85786-203",
"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": "Dr Simi Cetirizine Hydrochloride 10 mg",
"active_ingred_unit": "mg/1",
"application_number": "ANDA076047",
"marketing_category": "ANDA",
"nonproprietary_name": "Cetirizine Hydrochloride 10 mg",
"start_marketing_date": "20260101",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code R06AE.
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