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United States · US · US:66715-9748_0e8487fc-3e0e-bbfc-e063-6394a90a3073

Pepcid AC

Orange BookUNIISPLATC A02BA03

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

Identification

ManufacturerLil' Drug Store Products, Inc.
CountryUS (United States)
ATC codeA02BA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6671597488
    5 BLISTER PACK in 1 CARTON (66715-9748-8) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
N020325
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "5QZO15J2Z8",
    "rxcui": "4278",
    "inchikey": "XUFQPHANEAPEMJ-UHFFFAOYSA-N",
    "display_name": "FAMOTIDINE",
    "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": "66715-9748_0e8487fc-3e0e-bbfc-e063-6394a90a3073",
  "productndc": "66715-9748",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "020325",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Apr 28, 1995"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Sep 23, 2003"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "FAMOTIDINE",
  "proprietary_name": "Pepcid AC",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA020325",
  "marketing_category": "NDA",
  "nonproprietary_name": "Famotidine",
  "start_marketing_date": "20200401",
  "active_numerator_strength": "20"
}

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