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United States · US · US:0615-8565_edb36c02-fd49-4de3-b697-cdb6d14cd314
levocetirizine dihydrochloride
Orange BookUNIISPLATC R06AE09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerNCS HealthCare of KY, LLC dba Vangard Labs
CountryUS (United States)
ATC codeR06AE09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11061585653930 TABLET in 1 BLISTER PACK (0615-8565-39)
Annotations
UNII (FDA Substance ID)
SOD6A38AGA
LEVOCETIRIZINE DIHYDROCHLORIDE
RxCUI 402349
Orange Book
A203646
AB
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": {
"8274ca80-e7d3-4f4f-9901-cc5c589b4fef": {
"match": "brand_token",
"title": "LEVOCETIRIZINE DIHYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]",
"spl_version": "102",
"published_date": "2026-05-25"
}
},
"productid": "0615-8565_edb36c02-fd49-4de3-b697-cdb6d14cd314",
"productndc": "0615-8565",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "203646",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Sep 9, 2014"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVOCETIRIZINE DIHYDROCHLORIDE",
"proprietary_name": "levocetirizine dihydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA203646",
"marketing_category": "ANDA",
"nonproprietary_name": "levocetirizine dihydrochloride",
"start_marketing_date": "20140909",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code R06AE09.
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