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United States · US · US:0363-1606_22a37aee-5811-616b-a794-4c24bd940d73

Fexofenadine HCl and Pseudoephedrine HCI

Orange BookUNIISPLATC R06AX

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerWalgreens Company
CountryUS (United States)
ATC codeR06AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0363160620
    4 BLISTER PACK in 1 CARTON (0363-1606-20) / 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    0363160630
    6 BLISTER PACK in 1 CARTON (0363-1606-30) / 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": "0363-1606_22a37aee-5811-616b-a794-4c24bd940d73",
  "productndc": "0363-1606",
  "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": "20190916",
  "active_numerator_strength": "60; 120"
}

Related drugs

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