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United States · US · US:82667-015_33794d74-d742-82b5-e063-6294a90a6f32
ZERVIATE
Orange BookUNIISPLATC R06AE07
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHarrow Eye, LLC
CountryUS (United States)
ATC codeR06AE07
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1182667015241 POUCH in 1 CARTON (82667-015-24) / 30 VIAL, SINGLE-USE in 1 POUCH / 2.5 mL in 1 VIAL, SINGLE-USE
Annotations
UNII (FDA Substance ID)
YO7261ME24
CETIRIZINE
RxCUI 20610
Orange Book
N208694
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "YO7261ME24",
"rxcui": "20610",
"inchikey": "ZKLPARSLTMPFCP-UHFFFAOYSA-N",
"display_name": "CETIRIZINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"6fc5ef4e-4aea-4c34-8d51-0c07ab9aad59": {
"match": "brand_token",
"title": "ZERVIATE (CETIRIZINE) FOR SOLUTION [HARROW EYE, LLC]",
"spl_version": "2",
"published_date": "2025-04-30"
}
},
"productid": "82667-015_33794d74-d742-82b5-e063-6294a90a6f32",
"productndc": "82667-015",
"dosage_form": "FOR SOLUTION",
"orange_book": {
"appl_no": "208694",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 0.24% BASE",
"product_no": "001",
"approval_date": "May 30, 2017"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CETIRIZINE",
"proprietary_name": "ZERVIATE",
"active_ingred_unit": "mg/mL",
"application_number": "NDA208694",
"marketing_category": "NDA",
"nonproprietary_name": "cetirizine",
"start_marketing_date": "20250430",
"active_numerator_strength": "2.4"
}Related drugs
Other records sharing ATC code R06AE07.
- CAAG-CETIRIZINEANGITA PHARMA INC.
- NLAlbert Heijn Hooikoortstabletten Cetirizine diHCl 10 mg, filmomhulde tablettenCentrafarm B.V.
- PLAlermedPrzedsiębiorstwo Farmaceutyczne LEK-AM Sp. z o.o.
- PLAlerzinaSilesian Pharma Sp. z o.o.
- GBAllacan 10mg tabletsBristol Laboratories Ltd
- PLAlleMaxDr. Max Pharma s.r.o.
- NLAllergietabletten HTP Cetirizine diHCl 10 mg, filmomhulde tablettenHealthypharm B.V.
- CAALLERGY RELIEFAPOTEX INC
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