🇺🇸
United States · US · US:68391-955_6098f8c4-4502-287f-cd05-06e17d773116
levocetirizine dihydrochloride
Orange BookUNIISPLATC R06AE09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBJWC (Berkley & Jensen / BJ'S)
CountryUS (United States)
ATC codeR06AE09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1168391955112 BOTTLE in 1 PACKAGE (68391-955-11) / 55 TABLET, COATED in 1 BOTTLE (68391-955-55)
Annotations
UNII (FDA Substance ID)
SOD6A38AGA
LEVOCETIRIZINE DIHYDROCHLORIDE
RxCUI 402349
Orange Book
A210375
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": "68391-955_6098f8c4-4502-287f-cd05-06e17d773116",
"productndc": "68391-955",
"dosage_form": "TABLET, COATED",
"orange_book": {
"appl_no": "210375",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG",
"product_no": "001",
"approval_date": "Jan 19, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "LEVOCETIRIZINE DIHYDROCHLORIDE",
"proprietary_name": "levocetirizine dihydrochloride",
"active_ingred_unit": "mg/1",
"application_number": "ANDA210375",
"marketing_category": "ANDA",
"nonproprietary_name": "levocetirizine dihydrochloride",
"start_marketing_date": "20200624",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code R06AE09.
Access this data programmatically
Query levocetirizine dihydrochloride and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.