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United States · US · US:70000-0157_3987ffc4-5b9d-465e-a269-5dadb8ce95b2

Leader Ibuprofen PM

Orange BookUNIISPLATC D04AA

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

Identification

ManufacturerCardinal Health 110, LLC. dba Leader
CountryUS (United States)
ATC codeD04AA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    7000001571
    1 BOTTLE in 1 CARTON (70000-0157-1) / 40 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    7000001573
    1 BOTTLE in 1 CARTON (70000-0157-3) / 20 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
4OD433S209
DIPHENHYDRAMINE CITRATE
RxCUI 82004
Orange Book
A079113
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "4OD433S209",
    "rxcui": "82004",
    "inchikey": "SPCKHVPPRJWQRZ-UHFFFAOYSA-N",
    "display_name": "DIPHENHYDRAMINE CITRATE",
    "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": "70000-0157_3987ffc4-5b9d-465e-a269-5dadb8ce95b2",
  "productndc": "70000-0157",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "079113",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "38MG;200MG",
        "product_no": "001",
        "approval_date": "Dec 22, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "DIPHENHYDRAMINE CITRATE; IBUPROFEN",
  "proprietary_name": "Leader Ibuprofen PM",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA079113",
  "marketing_category": "ANDA",
  "nonproprietary_name": "diphenhydramine citrate, ibuprofen",
  "start_marketing_date": "20161123",
  "active_numerator_strength": "38; 200"
}

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