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United States · US · US:43063-479_3ed97d6e-d710-dd18-e063-6294a90ac4ae
Levocetirizine Dihydrochloride
Orange BookUNIISPLATC R06AE09
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPD-Rx Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeR06AE09
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11430634793030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-479-30)
Annotations
UNII (FDA Substance ID)
SOD6A38AGA
LEVOCETIRIZINE DIHYDROCHLORIDE
RxCUI 402349
Orange Book
A090199
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": "43063-479_3ed97d6e-d710-dd18-e063-6294a90ac4ae",
"productndc": "43063-479",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "090199",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Aug 22, 2011"
}
],
"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": "ANDA090199",
"marketing_category": "ANDA",
"nonproprietary_name": "Levocetirizine Dihydrochloride",
"start_marketing_date": "20110906",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code R06AE09.
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