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United States · US · US:0363-2600_b4975e3b-a036-49da-b220-3bc1d07c5a2b

Children Allergy

Orange BookUNIISPLATC R06AX26

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

Identification

ManufacturerWalgreens
CountryUS (United States)
ATC codeR06AX26
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0363260004
    1 BOTTLE, PLASTIC in 1 BOX (0363-2600-04) / 118 mL in 1 BOTTLE, PLASTIC
  • ndc11
    0363260008
    1 BOTTLE, PLASTIC in 1 BOX (0363-2600-08) / 237 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
2S068B75ZU
FEXOFENADINE HYDROCHLORIDE
RxCUI 236474
Orange Book
A203330
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": {
    "a26c3515-4a24-4988-b9bb-813420b15630": {
      "match": "brand_token",
      "title": "CHILDREN ALLERGY (FEXOFENADINE HCL) SUSPENSION [H E B]",
      "spl_version": "3",
      "published_date": "2026-05-13"
    }
  },
  "productid": "0363-2600_b4975e3b-a036-49da-b220-3bc1d07c5a2b",
  "productndc": "0363-2600",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "203330",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "30MG/5ML",
        "product_no": "001",
        "approval_date": "Nov 18, 2014"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "30MG/5ML",
        "product_no": "002",
        "approval_date": "Nov 18, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "FEXOFENADINE HYDROCHLORIDE",
  "proprietary_name": "Children Allergy",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA203330",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Fexofenadine HCL",
  "start_marketing_date": "20231031",
  "active_numerator_strength": "30"
}

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