Pepcid Complete

In shortageOrange BookUNIISPLATC A02BA

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

Identification

ManufacturerJC World Bell Wholesale Co., Inc.

CountryUS (United States)

ATC codeA02BA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
5026901601
6 BLISTER PACK in 1 BOX (50269-016-01) / 1 TABLET, CHEWABLE in 1 BLISTER PACK
ndc11
5026901602
6 BLISTER PACK in 1 BOX (50269-016-02) / 2 TABLET, CHEWABLE in 1 BLISTER PACK
ndc11
5026901625
25 POUCH in 1 BOX (50269-016-25) / 1 TABLET, CHEWABLE in 1 POUCH

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": "50269-016_2a950ee0-8ed6-565d-e063-6294a90a3086",
  "productndc": "50269-016",
  "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, MAGNESIUM HYDROXIDE",
  "start_marketing_date": "20200901",
  "active_numerator_strength": "800; 10; 165"
}

Related drugs

Other records sharing ATC code A02BA.

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