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United States · US · US:70000-0611_edf22989-fa56-4d83-9b88-912e0d14ac86

leader migraine relief

In shortageOrange BookUNIISPLATC N02BE

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

Identification

ManufacturerCardinal Health 110, LLC. dba Leader
CountryUS (United States)
ATC codeN02BE
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7000006111
    1 BOTTLE in 1 CARTON (70000-0611-1) / 80 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A075794
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Acetaminophen; Oxycodone Hydrochloride Tablet
Raw payload (JSON)
{
  "unii": {
    "unii": "362O9ITL9D",
    "rxcui": "161",
    "inchikey": "RZVAJINKPMORJF-UHFFFAOYSA-N",
    "display_name": "ACETAMINOPHEN",
    "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": "70000-0611_edf22989-fa56-4d83-9b88-912e0d14ac86",
  "productndc": "70000-0611",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "075794",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "250MG;250MG;65MG",
        "product_no": "001",
        "approval_date": "Nov 26, 2001"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
  "shortage_reason": "Acetaminophen; Oxycodone Hydrochloride Tablet",
  "shortage_status": "current",
  "proprietary_name": "leader migraine relief",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "ANDA075794",
  "marketing_category": "ANDA",
  "nonproprietary_name": "acetaminophen, aspirin, caffeine",
  "start_marketing_date": "20220808",
  "active_numerator_strength": "250; 250; 65"
}

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