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United States · US · US:42571-312_2e504864-a08d-48e1-e063-6394a90a92ed
Levocetirizine Dihydrochloride
Orange BookUNIISPLATC R06AE09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMicro Labs Limited
CountryUS (United States)
ATC codeR06AE09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 4
- ndc114257131211100 BLISTER PACK in 1 CARTON (42571-312-11) / 10 TABLET in 1 BLISTER PACK (42571-312-32)
- ndc1142571312181 BOTTLE in 1 CARTON (42571-312-18) / 10 TABLET in 1 BOTTLE
- ndc1142571312532500 TABLET in 1 POUCH (42571-312-53)
- ndc1142571312901 BOTTLE in 1 CARTON (42571-312-90) / 90 TABLET in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
SOD6A38AGA
LEVOCETIRIZINE DIHYDROCHLORIDE
RxCUI 402349
Orange Book
A211551
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": "42571-312_2e504864-a08d-48e1-e063-6394a90a92ed",
"productndc": "42571-312",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "211551",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "5MG",
"product_no": "001",
"approval_date": "Nov 20, 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": "ANDA211551",
"marketing_category": "ANDA",
"nonproprietary_name": "Levocetirizine Dihydrochloride",
"start_marketing_date": "20190201",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code R06AE09.
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