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United States · US · US:66715-9822_0fcbbeb6-b37d-ca2c-e063-6394a90a23ea

Pepcid Complete

In shortageOrange BookUNIISPLATC A02BA

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

Identification

ManufacturerLil' Drug Store Products, Inc.
CountryUS (United States)
ATC codeA02BA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6671598222
    2 POUCH in 1 CARTON (66715-9822-2) / 1 TABLET, CHEWABLE in 1 POUCH
  • ndc11
    6671598223
    3 POUCH in 1 CARTON (66715-9822-3) / 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": "66715-9822_0fcbbeb6-b37d-ca2c-e063-6394a90a23ea",
  "productndc": "66715-9822",
  "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 Chewable Tablet",
  "start_marketing_date": "20200717",
  "active_numerator_strength": "800; 10; 165"
}

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