Heartburn Relief

Orange BookUNIISPLATC A02BA03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerShield Pharmaceuticals Corp

CountryUS (United States)

ATC codeA02BA03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8305900315
1 BOTTLE in 1 PACKAGE (83059-0031-5) / 50 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

5QZO15J2Z8

FAMOTIDINE

RxCUI 4278

Orange Book

A215766

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": "83059-0031_4276c109-6851-5045-e063-6294a90a592e",
  "productndc": "83059-0031",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "215766",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Nov 8, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Nov 8, 2021"
      }
    ],
    "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": "ANDA215766",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Famotidine",
  "start_marketing_date": "20240611",
  "active_numerator_strength": "10"
}

Related drugs

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