🇺🇸
United States · US · US:37808-022_8c74b0a5-6bbc-0f8d-bbda-46d6cb39aea6
Fexofenadine HCl and Pseudoephedrine HCI
Orange BookUNIISPLATC R06AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerHEB
CountryUS (United States)
ATC codeR06AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1137808022316 BLISTER PACK in 1 CARTON (37808-022-31) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
2S068B75ZU
FEXOFENADINE HYDROCHLORIDE
RxCUI 236474
Orange Book
A076667
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": "37808-022_8c74b0a5-6bbc-0f8d-bbda-46d6cb39aea6",
"productndc": "37808-022",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "076667",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "60MG;120MG",
"product_no": "001",
"approval_date": "Nov 18, 2014"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"proprietary_name": "Fexofenadine HCl and Pseudoephedrine HCI",
"active_ingred_unit": "mg/1; mg/1",
"application_number": "ANDA076667",
"marketing_category": "ANDA",
"nonproprietary_name": "Fexofenadine HCl and Pseudoephedrine HCI",
"start_marketing_date": "20151221",
"active_numerator_strength": "60; 120"
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