Childrens Fexofenadine Hydrochloride

Orange BookUNIISPLATC R06AX26

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerWal-Mart Stores Inc

CountryUS (United States)

ATC codeR06AX26

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7990330604
1 BOTTLE in 1 CARTON (79903-306-04) / 120 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

2S068B75ZU

FEXOFENADINE HYDROCHLORIDE

RxCUI 236474

Orange Book

A208123

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": {
    "436c0126-4ff3-c082-e063-6294a90a3d72": {
      "match": "brand_token",
      "title": "CHILDRENS IBUPROFEN (IBUPROFEN) SUSPENSION [KESIN PHARMA CORPORATION]",
      "spl_version": "2",
      "published_date": "2026-06-01"
    }
  },
  "productid": "79903-306_2905c49e-1ab8-3d84-e063-6394a90ac1a4",
  "productndc": "79903-306",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "208123",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "30MG/5ML",
        "product_no": "001",
        "approval_date": "Nov 9, 2017"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "30MG/5ML",
        "product_no": "002",
        "approval_date": "Nov 9, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "FEXOFENADINE HYDROCHLORIDE",
  "proprietary_name": "Childrens Fexofenadine Hydrochloride",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA208123",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fexofenadine Hydrochloride",
  "start_marketing_date": "20241206",
  "active_numerator_strength": "30"
}

Related drugs

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