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United States · US · US:71335-0789_4677b1a2-8516-44c2-9d61-0f033b40617c
Levocetirizine Dihydrochloride
Orange BookUNIISPLATC R06AE09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeR06AE09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc11713350789130 TABLET in 1 BOTTLE (71335-0789-1)
- ndc11713350789290 TABLET in 1 BOTTLE (71335-0789-2)
- ndc11713350789328 TABLET in 1 BOTTLE (71335-0789-3)
- ndc11713350789460 TABLET in 1 BOTTLE (71335-0789-4)
Annotations
UNII (FDA Substance ID)
SOD6A38AGA
LEVOCETIRIZINE DIHYDROCHLORIDE
RxCUI 402349
Orange Book
A091264
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": "71335-0789_4677b1a2-8516-44c2-9d61-0f033b40617c",
"productndc": "71335-0789",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "091264",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Jun 29, 2012"
}
],
"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": "ANDA091264",
"marketing_category": "ANDA",
"nonproprietary_name": "Levocetirizine Dihydrochloride",
"start_marketing_date": "20120629",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code R06AE09.
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