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United States · US · US:0904-5529_4bbca900-8593-427c-8595-c5c6c3456967

heartburn relief

Orange BookUNIISPLATC A02BA03

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

Identification

ManufacturerMajor Pharmaceuticals
CountryUS (United States)
ATC codeA02BA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0904552952
    1 BOTTLE in 1 CARTON (0904-5529-52) / 60 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    0904552987
    30 BLISTER PACK in 1 CARTON (0904-5529-87) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
A075400
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": {
    "35e12e83-5808-4f78-bcd5-33217a0d291b": {
      "match": "brand_token",
      "title": "HEARTBURN (GARLIC, BERBERIS VULGARIS ROOT, CALENDULA OFFICINALIS FLOWERING TOP, IRIS VERSICOLOR ROOT, GINGER, AND VALERIAN) SOLUTION/ DROPS [FORCES OF NATURE]",
      "spl_version": "4",
      "published_date": "2026-05-07"
    }
  },
  "productid": "0904-5529_4bbca900-8593-427c-8595-c5c6c3456967",
  "productndc": "0904-5529",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "075400",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Mar 18, 2005"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "FAMOTIDINE",
  "proprietary_name": "heartburn relief",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075400",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Famotidine",
  "start_marketing_date": "20090909",
  "active_numerator_strength": "10"
}

Related drugs

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