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United States · US · US:70000-0162_2aa29226-da73-4113-9dbd-ed13b345464d

Leader Allergy Relief D-24

Orange BookUNIISPLATC R06AX

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

Identification

ManufacturerCardinal Health
CountryUS (United States)
ATC codeR06AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7000001621
    10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70000-0162-1)
  • ndc11
    7000001622
    15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70000-0162-2)

Annotations

UNII (FDA Substance ID)
7AJO3BO7QN
LORATADINE
RxCUI 28889
Orange Book
A076557
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "7AJO3BO7QN",
    "rxcui": "28889",
    "inchikey": "JCCNYMKQOSZNPW-UHFFFAOYSA-N",
    "display_name": "LORATADINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "12971fb2-2314-4443-bf70-b7eb5859b148": {
      "match": "brand_token",
      "title": "LEADER MUCUS RELIEF D (GUAIFENESIN, PSEUDOEPHEDRINE HYDROCHLORIDE) TABLET, MULTILAYER, EXTENDED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER]",
      "spl_version": "3",
      "published_date": "2026-06-01"
    }
  },
  "productid": "70000-0162_2aa29226-da73-4113-9dbd-ed13b345464d",
  "productndc": "70000-0162",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "076557",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG;240MG",
        "product_no": "001",
        "approval_date": "Sep 22, 2004"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "LORATADINE; PSEUDOEPHEDRINE SULFATE",
  "proprietary_name": "Leader Allergy Relief D-24",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA076557",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loratadine and Pseudoephedrine Sulfate",
  "start_marketing_date": "20170215",
  "active_numerator_strength": "10; 240"
}

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