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United States · US · US:50090-1203_a0388348-fc41-4d13-81ad-d8f25cd154d9

ALLEGRA-D

Orange BookUNIISPLATC R06AX

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeR06AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009012030
    1 BLISTER PACK in 1 CARTON (50090-1203-0) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
2S068B75ZU
FEXOFENADINE HYDROCHLORIDE
RxCUI 236474
Orange Book
N020786
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": {
    "b32e172a-abf5-4c17-aa39-19e517952b91": {
      "match": "brand_token",
      "title": "ALLEGRA-D ALLERGY AND CONGESTION (FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [CHATTEM, INC.]",
      "spl_version": "37",
      "published_date": "2026-01-12"
    }
  },
  "productid": "50090-1203_a0388348-fc41-4d13-81ad-d8f25cd154d9",
  "productndc": "50090-1203",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "020786",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "60MG;120MG",
        "product_no": "002",
        "approval_date": "Jan 24, 2011"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
  "proprietary_name": "ALLEGRA-D",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "NDA020786",
  "marketing_category": "NDA",
  "nonproprietary_name": "fexofenadine hydrochloride and pseudoephedrine hydrochloride",
  "start_marketing_date": "20110303",
  "active_numerator_strength": "60; 120"
}

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