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United States · US · US:16837-855_21af0de6-18c5-b8e8-e063-6394a90af51f

PEPCID AC

Orange BookUNIISPLATC A02BA03

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

Identification

ManufacturerKenvue Brands LLC
CountryUS (United States)
ATC codeA02BA03
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 18

  • ndc11
    1683785502
    2 POUCH in 1 CARTON (16837-855-02) / 1 TABLET, FILM COATED in 1 POUCH
  • ndc11
    1683785509
    1 BOTTLE, PLASTIC in 1 PACKAGE (16837-855-09) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    1683785512
    1 BOTTLE, PLASTIC in 1 CARTON (16837-855-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    1683785513
    1 TABLET, FILM COATED in 1 POUCH (16837-855-13)
  • ndc11
    1683785514
    5 BLISTER PACK in 1 CARTON (16837-855-14) / 5 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    1683785515
    1 BOTTLE, PLASTIC in 1 CARTON (16837-855-15) / 35 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    1683785516
    1 BOTTLE, PLASTIC in 1 CARTON (16837-855-16) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    1683785518
    1 BOTTLE, PLASTIC in 1 CARTON (16837-855-18) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    1683785519
    1 BLISTER PACK in 1 CARTON (16837-855-19) / 8 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    1683785520
    2 CARTON in 1 PACKAGE (16837-855-20) / 1 BOTTLE, PLASTIC in 1 CARTON / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    1683785524
    2500 POUCH in 1 CARTON (16837-855-24) / 1 TABLET, FILM COATED in 1 POUCH
  • ndc11
    1683785550
    1 BOTTLE, PLASTIC in 1 CARTON (16837-855-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    1683785552
    50 POUCH in 1 TRAY (16837-855-52) / 1 TABLET, FILM COATED in 1 POUCH
  • ndc11
    1683785570
    1 BOTTLE, PLASTIC in 1 CARTON (16837-855-70) / 70 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    1683785575
    1 BOTTLE, PLASTIC in 1 CARTON (16837-855-75) / 75 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    1683785580
    1 BOTTLE, PLASTIC in 1 CARTON (16837-855-80) / 80 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    1683785585
    1 BOTTLE, PLASTIC in 1 CARTON (16837-855-85) / 85 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    1683785590
    125 TABLET, FILM COATED in 1 PACKAGE, COMBINATION (16837-855-90)

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": "16837-855_21af0de6-18c5-b8e8-e063-6394a90af51f",
  "productndc": "16837-855",
  "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": "20030901",
  "active_numerator_strength": "20"
}

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