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United States · US · US:37808-999_1f6d54d4-f124-4194-b6dc-b9e37fd54faa

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

Orange BookUNIISPLATC R06AX

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

Identification

ManufacturerH E B
CountryUS (United States)
ATC codeR06AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    3780899930
    1 BLISTER PACK in 1 CARTON (37808-999-30) / 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
2S068B75ZU
FEXOFENADINE HYDROCHLORIDE
RxCUI 236474
Orange Book
A090818
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": "37808-999_1f6d54d4-f124-4194-b6dc-b9e37fd54faa",
  "productndc": "37808-999",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "090818",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "60MG;120MG",
        "product_no": "001",
        "approval_date": "Jan 29, 2015"
      }
    ],
    "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": "ANDA090818",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride",
  "start_marketing_date": "20180801",
  "active_numerator_strength": "60; 120"
}

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