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United States · US · US:70264-034_43c8f02d-6724-ad9f-e063-6294a90a0702

Pepcid Complete

In shortageOrange BookUNIISPLATC A02BA

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

Identification

ManufacturerR J General Corporation
CountryUS (United States)
ATC codeA02BA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7026403401
    50 TABLET, CHEWABLE in 1 CARTON (70264-034-01)

Annotations

UNII (FDA Substance ID)
H0G9379FGK
CALCIUM CARBONATE
RxCUI 1897
Orange Book
N020958
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": {
    "e874118f-b4fe-4c80-aece-99ea20e7e805": {
      "match": "brand_token",
      "title": "PEPCID COMPLETE (FAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDE) TABLET, CHEWABLE [KENVUE BRANDS LLC]",
      "spl_version": "25",
      "published_date": "2026-03-26"
    }
  },
  "productid": "70264-034_43c8f02d-6724-ad9f-e063-6294a90a0702",
  "productndc": "70264-034",
  "dosage_form": "TABLET, CHEWABLE",
  "orange_book": {
    "appl_no": "020958",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "800MG;10MG;165MG",
        "product_no": "001",
        "approval_date": "Oct 16, 2000"
      }
    ],
    "appl_type": "N"
  },
  "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": "Pepcid Complete",
  "active_ingred_unit": "mg/1; mg/1; mg/1",
  "application_number": "NDA020958",
  "marketing_category": "NDA",
  "nonproprietary_name": "famotidine, calcium carbonate, and magnesium hydroxide",
  "start_marketing_date": "20220109",
  "active_numerator_strength": "800; 10; 165"
}

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