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United States · US · US:78206-120_64c0d4d8-2434-45c4-801e-710026c5b07f
CLARINEX-D 12 HOUR
Orange BookUNIISPLATC R06AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerOrganon LLC
CountryUS (United States)
ATC codeR06AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc117820612001100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (78206-120-01)
Annotations
UNII (FDA Substance ID)
FVF865388R
DESLORATADINE
RxCUI 275635
Orange Book
N021313
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": {
"1af66b7a-4ab8-40d8-abdd-22d3310228a8": {
"match": "brand_token",
"title": "CLARINEX-D 12 HOUR (DESLORATADINE AND PSEUDOEPHEDRINE SULFATE) TABLET, EXTENDED RELEASE [ORGANON LLC]",
"spl_version": "6",
"published_date": "2025-11-17"
}
},
"productid": "78206-120_64c0d4d8-2434-45c4-801e-710026c5b07f",
"productndc": "78206-120",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "021313",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "2.5MG;120MG",
"product_no": "001",
"approval_date": "Feb 1, 2006"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DESLORATADINE; PSEUDOEPHEDRINE SULFATE",
"proprietary_name": "CLARINEX-D 12 HOUR",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "NDA021313",
"marketing_category": "NDA",
"nonproprietary_name": "desloratadine and pseudoephedrine sulfate",
"start_marketing_date": "20210601",
"active_numerator_strength": "2.5; 120"
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