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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

  • ndc11
    7067710101
    4 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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