Back to search
🇺🇸

United States · US · US:57483-250_b1644d9c-353b-44bf-b3f9-9bd8b83976f2

Crcle Cetirizine Hydrochloride

Orange BookUNIIATC R06AE

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerInnovus Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeR06AE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5748325001
    365 TABLET in 1 CONTAINER (57483-250-01)

Annotations

UNII (FDA Substance ID)
64O047KTOA
CETIRIZINE HYDROCHLORIDE
RxCUI 203150
Orange Book
A209274
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",
  "productid": "57483-250_b1644d9c-353b-44bf-b3f9-9bd8b83976f2",
  "productndc": "57483-250",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "209274",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Dec 22, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "Crcle Cetirizine Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA209274",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cetirizine Hydrochloride",
  "start_marketing_date": "20210630",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code R06AE.

Access this data programmatically

Query Crcle Cetirizine Hydrochloride 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.