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United States · US · US:70000-0416_825f38dd-c5f6-4871-a3f5-483263755639

leader acid reducer complete

In shortageOrange BookUNIISPLATC A02BA

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

Identification

ManufacturerCardinal Health 110, LLC. dba Leader
CountryUS (United States)
ATC codeA02BA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7000004161
    25 TABLET, CHEWABLE in 1 BOTTLE (70000-0416-1)

Annotations

UNII (FDA Substance ID)
H0G9379FGK
CALCIUM CARBONATE
RxCUI 1897
Orange Book
A077355
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Calcium Chloride Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "H0G9379FGK",
    "rxcui": "1897",
    "inchikey": "VTYYLEPIZMXCLO-UHFFFAOYSA-L",
    "display_name": "CALCIUM CARBONATE",
    "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": "70000-0416_825f38dd-c5f6-4871-a3f5-483263755639",
  "productndc": "70000-0416",
  "dosage_form": "TABLET, CHEWABLE",
  "orange_book": {
    "appl_no": "077355",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "800MG;10MG;165MG",
        "product_no": "001",
        "approval_date": "Feb 6, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE",
  "shortage_reason": "Calcium Chloride Injection",
  "shortage_status": "current",
  "proprietary_name": "leader acid reducer complete",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "ANDA077355",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Famotidine, Calcium Carbonate, Magnesium Hydroxide",
  "start_marketing_date": "20180928",
  "active_numerator_strength": "800; 10; 165"
}

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