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United States · US · US:10135-639_f380ef7e-eece-412d-b50c-deae2f6098d5
Levocetirizine Dihydrochloride
Orange BookUNIISPLATC R06AE09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMarlex Pharmaceuticals Inc
CountryUS (United States)
ATC codeR06AE09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11101356393030 TABLET, FILM COATED in 1 BOTTLE (10135-639-30)
- ndc11101356399090 TABLET, FILM COATED in 1 BOTTLE (10135-639-90)
Annotations
UNII (FDA Substance ID)
SOD6A38AGA
LEVOCETIRIZINE DIHYDROCHLORIDE
RxCUI 402349
Orange Book
A202046
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": "10135-639_f380ef7e-eece-412d-b50c-deae2f6098d5",
"productndc": "10135-639",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "202046",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Sep 17, 2013"
}
],
"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": "ANDA202046",
"marketing_category": "ANDA",
"nonproprietary_name": "levocetirizine Dihydrochloride",
"start_marketing_date": "20180901",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code R06AE09.
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