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United States · US · US:41167-4121_fb8ea8ca-b8a9-46af-9c21-d2df1100e9ff

Allegra Allergy

Orange BookUNIISPLATC R06AX26

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

Identification

ManufacturerChattem, Inc.
CountryUS (United States)
ATC codeR06AX26
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    4116741211
    1 BOTTLE in 1 CARTON (41167-4121-1) / 60 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    4116741214
    1 BOTTLE, PLASTIC in 1 CARTON (41167-4121-4) / 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
2S068B75ZU
FEXOFENADINE HYDROCHLORIDE
RxCUI 236474
Orange Book
N020872
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": {
    "b82d993a-16ff-4037-a182-7010de8e1cdd": {
      "match": "brand_token",
      "title": "ALLEGRA ALLERGY (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED ALLEGRA ALLERGY, TRAVEL BASIX (FEXOFENADINE HYDROCHLORIDE) TABLET, FILM COATED [LIL' DRUG STORE PRODUCTS, INC]",
      "spl_version": "9",
      "published_date": "2026-04-29"
    }
  },
  "productid": "41167-4121_fb8ea8ca-b8a9-46af-9c21-d2df1100e9ff",
  "productndc": "41167-4121",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "020872",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**",
        "product_no": "005",
        "approval_date": "Jan 24, 2011"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "30MG",
        "product_no": "006",
        "approval_date": "Jan 24, 2011"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "60MG",
        "product_no": "007",
        "approval_date": "Jan 24, 2011"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "60MG",
        "product_no": "008",
        "approval_date": "Jan 24, 2011"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "180MG",
        "product_no": "009",
        "approval_date": "Jan 24, 2011"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "180MG",
        "product_no": "010",
        "approval_date": "Jan 24, 2011"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "FEXOFENADINE HYDROCHLORIDE",
  "proprietary_name": "Allegra Allergy",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020872",
  "marketing_category": "NDA",
  "nonproprietary_name": "fexofenadine hydrochloride",
  "start_marketing_date": "20110303",
  "active_numerator_strength": "180"
}

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