🇺🇸
United States · US · US:70677-1010_c604326c-44ff-2c88-4d4f-d5279566bf8d
Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride
Orange BookUNIISPLATC R06AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerStrategic Sourcing Services, LLC
CountryUS (United States)
ATC codeR06AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1170677101014 BLISTER PACK in 1 CARTON (70677-1010-1) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
2S068B75ZU
FEXOFENADINE HYDROCHLORIDE
RxCUI 236474
Orange Book
A215434
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": "70677-1010_c604326c-44ff-2c88-4d4f-d5279566bf8d",
"productndc": "70677-1010",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "215434",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "60MG;120MG",
"product_no": "001",
"approval_date": "May 31, 2022"
}
],
"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": "ANDA215434",
"marketing_category": "ANDA",
"nonproprietary_name": "Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride",
"start_marketing_date": "20220331",
"active_numerator_strength": "60; 120"
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