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United States · US · US:41167-5804_87a83f00-5abf-437d-af13-394c22964050

Xyzal

Orange BookUNIISPLATC R06AE09

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

Identification

ManufacturerChattem, Inc.
CountryUS (United States)
ATC codeR06AE09
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    4116758045
    1 BOTTLE in 1 CARTON (41167-5804-5) / 148 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
SOD6A38AGA
LEVOCETIRIZINE DIHYDROCHLORIDE
RxCUI 402349
Orange Book
N022064
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "SOD6A38AGA",
    "rxcui": "402349",
    "inchikey": "PGLIUCLTXOYQMV-GHVWMZMZSA-N",
    "display_name": "LEVOCETIRIZINE DIHYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "8be45c2a-1eca-4a00-81b9-f7babdbdcd41": {
      "match": "brand_token",
      "title": "XYZAL ALLERGY 24HR (LEVOCETIRIZINE DIHYDROCHLORIDE) TABLET [CHATTEM, INC.]",
      "spl_version": "14",
      "published_date": "2026-03-10"
    }
  },
  "productid": "41167-5804_87a83f00-5abf-437d-af13-394c22964050",
  "productndc": "41167-5804",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "022064",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "001",
        "approval_date": "May 25, 2007"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LEVOCETIRIZINE DIHYDROCHLORIDE",
  "proprietary_name": "Xyzal",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA022064",
  "marketing_category": "NDA",
  "nonproprietary_name": "levocetirizine dihydrochloride",
  "start_marketing_date": "20170724",
  "active_numerator_strength": ".5"
}

Related drugs

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