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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
- ndc1141167580451 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"strength": "5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",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
Other records sharing ATC code R06AE09.
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