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United States · US · US:63629-2533_acc7fd37-12cc-4319-ac53-eb35e3e18d04
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 · 1
- ndc1163629253311 BOTTLE in 1 CARTON (63629-2533-1) / 148 mL in 1 BOTTLE
Annotations
UNII (FDA Substance ID)
SOD6A38AGA
LEVOCETIRIZINE DIHYDROCHLORIDE
RxCUI 402349
Orange Book
A091263
AA
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": "63629-2533_acc7fd37-12cc-4319-ac53-eb35e3e18d04",
"productndc": "63629-2533",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "091263",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AA",
"strength": "2.5MG/5ML",
"product_no": "001",
"approval_date": "Nov 7, 2011"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "LEVOCETIRIZINE DIHYDROCHLORIDE",
"proprietary_name": "levocetirizine dihydrochloride",
"active_ingred_unit": "mg/mL",
"application_number": "ANDA091263",
"marketing_category": "ANDA",
"nonproprietary_name": "Levocetirizine dihydrochloride",
"start_marketing_date": "20111107",
"active_numerator_strength": ".5"
}Related drugs
Other records sharing ATC code R06AE09.
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