Indoor and Outdoor Allergy Relief

Orange BookUNIISPLATC R06AE

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerFamora Inc.

CountryUS (United States)

ATC codeR06AE

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8750900023
365 TABLET, COATED in 1 BOTTLE (87509-0002-3)

Annotations

UNII (FDA Substance ID)

64O047KTOA

CETIRIZINE HYDROCHLORIDE

RxCUI 203150

Orange Book

A077829

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": {
    "2a94d25c-aacf-4f5c-b406-815f0e1d0611": {
      "match": "brand_token",
      "title": "INDOOR AND OUTDOOR ALLERGY RELIEF (CETIRIZINE HCL) TABLET, COATED [FAMORA INC.]",
      "spl_version": "1",
      "published_date": "2026-03-20"
    }
  },
  "productid": "87509-0002_4d50d76d-12e9-17c0-e063-6394a90a4f6f",
  "productndc": "87509-0002",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "077829",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Aug 26, 2009"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "002",
        "approval_date": "Aug 26, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5MG",
        "product_no": "003",
        "approval_date": "Aug 26, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "004",
        "approval_date": "Aug 26, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CETIRIZINE HYDROCHLORIDE",
  "proprietary_name": "Indoor and Outdoor Allergy Relief",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077829",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cetirizine HCl",
  "start_marketing_date": "20260318",
  "active_numerator_strength": "25"
}

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