🇺🇸
United States · US · US:55111-557_29216032-68a5-566a-5eaf-ffc9cb597e9a
Fexofenadine HCl and Pseudoephedrine HCI
Orange BookUNIISPLATC R06AX
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerDr.Reddy's Laboratories Limited
CountryUS (United States)
ATC codeR06AX
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1155111557071 BLISTER PACK in 1 CARTON (55111-557-07) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1155111557293 BLISTER PACK in 1 CARTON (55111-557-29) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
- ndc1155111557352 BLISTER PACK in 1 CARTON (55111-557-35) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
Annotations
UNII (FDA Substance ID)
2S068B75ZU
FEXOFENADINE HYDROCHLORIDE
RxCUI 236474
Orange Book
A079043
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": "55111-557_29216032-68a5-566a-5eaf-ffc9cb597e9a",
"productndc": "55111-557",
"dosage_form": "TABLET, EXTENDED RELEASE",
"orange_book": {
"appl_no": "079043",
"products": [
{
"rs": false,
"rld": false,
"te_code": null,
"strength": "180MG;240MG",
"product_no": "002",
"approval_date": "Jun 22, 2011"
}
],
"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": "ANDA079043",
"marketing_category": "ANDA",
"nonproprietary_name": "Fexofenadine HCl and Pseudoephedrine HCI",
"start_marketing_date": "20110824",
"active_numerator_strength": "180; 240"
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