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United States · US · US:69452-363_63a77a01-b991-4f03-8f9f-4dd09c8302c4
Desloratadine
Orange BookUNIISPLATC R06AX27
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBionpharma Inc.
CountryUS (United States)
ATC codeR06AX27
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc116945236320100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-363-20)
- ndc116945236330500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69452-363-30)
Annotations
UNII (FDA Substance ID)
FVF865388R
DESLORATADINE
RxCUI 275635
Orange Book
A078357
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "FVF865388R",
"rxcui": "275635",
"inchikey": "JAUOIFJMECXRGI-UHFFFAOYSA-N",
"display_name": "DESLORATADINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"e4db30a5-48e5-4fe3-8793-30b6866f87c1": {
"match": "brand_token",
"title": "DESLORATADINE TABLET, FILM COATED [NATCO PHARMA USA LLC]",
"spl_version": "1",
"published_date": "2026-04-27"
}
},
"productid": "69452-363_63a77a01-b991-4f03-8f9f-4dd09c8302c4",
"productndc": "69452-363",
"dosage_form": "TABLET, FILM COATED",
"orange_book": {
"appl_no": "078357",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Feb 19, 2010"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DESLORATADINE",
"proprietary_name": "Desloratadine",
"active_ingred_unit": "mg/1",
"application_number": "ANDA078357",
"marketing_category": "ANDA",
"nonproprietary_name": "Desloratadine",
"start_marketing_date": "20231128",
"active_numerator_strength": "5"
}Related drugs
Other records sharing ATC code R06AX27.
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