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United States · US · US:70000-0176_ead9d7b1-1a6b-4b01-9c26-35b457c93eac

Leader Ibuprofen

Orange BookUNIISPLATC G02CC01

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

Identification

ManufacturerCardinal Health 110, LLC. dba Leader
CountryUS (United States)
ATC codeG02CC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7000001761
    1 BOTTLE in 1 CARTON (70000-0176-1) / 100 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    7000001764
    1 BOTTLE in 1 CARTON (70000-0176-4) / 50 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    7000001765
    1 BOTTLE in 1 CARTON (70000-0176-5) / 500 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A072096
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "WK2XYI10QM",
    "rxcui": "5640",
    "inchikey": "HEFNNWSXXWATRW-UHFFFAOYSA-N",
    "display_name": "IBUPROFEN",
    "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": "70000-0176_ead9d7b1-1a6b-4b01-9c26-35b457c93eac",
  "productndc": "70000-0176",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "072096",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Dec 8, 1987"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "Leader Ibuprofen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA072096",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen",
  "start_marketing_date": "20161130",
  "active_numerator_strength": "200"
}

Related drugs

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