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 · 9

ndc11
1683729812
100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-298-12)
ndc11
1683729825
25 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-298-25)
ndc11
1683729850
50 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-298-50)
ndc11
1683729852
50 POUCH in 1 CARTON (16837-298-52) / 1 TABLET, CHEWABLE in 1 POUCH
ndc11
1683729865
2500 POUCH in 1 CARTON (16837-298-65) / 1 TABLET, CHEWABLE in 1 POUCH
ndc11
1683729867
4 POUCH in 1 CARTON (16837-298-67) / 1 TABLET, CHEWABLE in 1 POUCH
ndc11
1683729868
8 POUCH in 1 CARTON (16837-298-68) / 1 TABLET, CHEWABLE in 1 POUCH
ndc11
1683729870
70 TABLET, CHEWABLE in 1 BOTTLE (16837-298-70)
ndc11
1683729872
72 TABLET, CHEWABLE in 1 BOTTLE (16837-298-72)

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": "16837-298_4cd2ca51-2077-9389-e063-6394a90a40e2",
  "productndc": "16837-298",
  "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": "20090301",
  "active_numerator_strength": "800; 10; 165"
}

Related drugs

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