🇺🇸
United States · US · US:70000-0677_c3b40d04-7eef-4c80-a604-808d2be72ad7
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Orange BookUNIISPLATC R06AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCardinal Health
CountryUS (United States)
ATC codeR06AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1170000067712 BLISTER PACK in 1 CARTON (70000-0677-1) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1170000067723 BLISTER PACK in 1 CARTON (70000-0677-2) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
2S068B75ZU
FEXOFENADINE HYDROCHLORIDE
RxCUI 236474
Orange Book
A209116
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "2S068B75ZU",
"rxcui": "236474",
"inchikey": "RRJFVPUCXDGFJB-UHFFFAOYSA-N",
"display_name": "FEXOFENADINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"52d50976-e63a-b3e3-e063-6294a90a6a97": {
"match": "brand_token",
"title": "FEXOFENADINE HCL TABLET [YYBA CORP]",
"spl_version": "1",
"published_date": "2026-06-01"
}
},
"productid": "70000-0677_c3b40d04-7eef-4c80-a604-808d2be72ad7",
"productndc": "70000-0677",
"dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
"orange_book": {
"appl_no": "209116",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "60MG;120MG",
"product_no": "001",
"approval_date": "Oct 30, 2017"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"proprietary_name": "Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA209116",
"marketing_category": "ANDA",
"nonproprietary_name": "Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride",
"start_marketing_date": "20240515",
"active_numerator_strength": "60; 120"
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