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United States · US · US:0904-5780_2b99e188-08ce-4160-bf19-136bc4dd39be

Major 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
    0904578017
    25 BLISTER PACK in 1 CARTON (0904-5780-17) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • ndc11
    0904578051
    1 BOTTLE in 1 CARTON (0904-5780-51) / 50 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
A077351
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": {
    "772889a1-fc68-4400-9612-6fa51d0b6878": {
      "match": "brand_token",
      "title": "MAJOR ORAL RINSE (0.12% CHLORHEXIDINE GLUCONATE) RINSE [CARDINAL HEALTH 107, LLC]",
      "spl_version": "6",
      "published_date": "2026-05-21"
    }
  },
  "productid": "0904-5780_2b99e188-08ce-4160-bf19-136bc4dd39be",
  "productndc": "0904-5780",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077351",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Sep 25, 2006"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "FAMOTIDINE",
  "proprietary_name": "Major Heartburn Relief",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077351",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Famotidine",
  "start_marketing_date": "20060929",
  "active_numerator_strength": "20"
}

Related drugs

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