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United States · US · US:70000-0736_6b244a54-3446-4f50-8782-65ebe07a6295

Leader 8HR Arthritis Pain Relief

Orange BookUNIISPLATC N02BE51

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

Identification

ManufacturerCardinal Health 110, LLC. dba Leader
CountryUS (United States)
ATC codeN02BE51
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7000007361
    1 BOTTLE in 1 CARTON (70000-0736-1) / 225 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
362O9ITL9D
ACETAMINOPHEN
RxCUI 161
Orange Book
A075077
DailyMed SPL labels
1 version tracked
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": "70000-0736_6b244a54-3446-4f50-8782-65ebe07a6295",
  "productndc": "70000-0736",
  "dosage_form": "TABLET, FILM COATED, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "075077",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "650MG",
        "product_no": "001",
        "approval_date": "Feb 25, 2000"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "ACETAMINOPHEN",
  "proprietary_name": "Leader 8HR Arthritis Pain Relief",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075077",
  "marketing_category": "ANDA",
  "nonproprietary_name": "acetaminophen",
  "start_marketing_date": "20251110",
  "active_numerator_strength": "650"
}

Related drugs

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