Pepcid Complete

In shortageOrange BookUNIISPLATC A02BA

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerKenvue Brands LLC

CountryUS (United States)

ATC codeA02BA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
1683724625
25 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-246-25)
ndc11
1683724650
50 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-246-50)

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": "16837-246_42d92ca2-a860-6e60-e063-6294a90af5b5",
  "productndc": "16837-246",
  "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": "20090101",
  "active_numerator_strength": "800; 10; 165"
}

Related drugs

Other records sharing ATC code A02BA.

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