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United States · US · US:51660-037_437a9779-39c2-6e34-e063-6294a90a55bf

Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride

Orange BookUNIISPLATC R06AX

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

Identification

ManufacturerOhm Laboratories Inc.
CountryUS (United States)
ATC codeR06AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    5166003721
    1 BLISTER PACK in 1 CARTON (51660-037-21) / 20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
  • ndc11
    5166003731
    1 BLISTER PACK in 1 CARTON (51660-037-31) / 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": "51660-037_437a9779-39c2-6e34-e063-6294a90a55bf",
  "productndc": "51660-037",
  "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": "20180301",
  "active_numerator_strength": "60; 120"
}

Related drugs

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