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United States · US · US:41167-3511_f43bc46c-c507-4ccf-9b93-17eaeebf4ed5

Xyzal Allergy 24HR

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 · 3

  • ndc11
    4116735112
    1 BLISTER PACK in 1 CARTON (41167-3511-2) / 20 TABLET in 1 BLISTER PACK
  • ndc11
    4116735118
    1 BLISTER PACK in 1 CARTON (41167-3511-8) / 40 TABLET in 1 BLISTER PACK
  • ndc11
    4116735119
    1 BLISTER PACK in 1 CARTON (41167-3511-9) / 60 TABLET in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
SOD6A38AGA
LEVOCETIRIZINE DIHYDROCHLORIDE
RxCUI 402349
Orange Book
N209089
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": "41167-3511_f43bc46c-c507-4ccf-9b93-17eaeebf4ed5",
  "productndc": "41167-3511",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "209089",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Jan 31, 2017"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LEVOCETIRIZINE DIHYDROCHLORIDE",
  "proprietary_name": "Xyzal Allergy 24HR",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA209089",
  "marketing_category": "NDA",
  "nonproprietary_name": "Levocetirizine dihydrochloride",
  "start_marketing_date": "20230901",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code R06AE09.

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