Back to search
🇺🇸

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

  • ndc11
    8266701524
    1 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.

Access this data programmatically

Query ZERVIATE and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.