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United States · US · US:85828-443_39e5e058-6419-4d47-ab41-d051f58065a1

Acid Reducer

Orange BookUNIISPLATC A02BA03

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

Identification

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

Packs · 1

  • ndc11
    8582844325
    1 BOTTLE in 1 CARTON (85828-443-25) / 25 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
A215822
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": {
    "9826dd26-5592-4f96-9274-005ef9462cb4": {
      "match": "brand_token",
      "title": "ACID RELIEF (FAMOTIDINE) TABLET, FILM COATED [RITE AID CORPORATION]",
      "spl_version": "5",
      "published_date": "2026-05-28"
    }
  },
  "productid": "85828-443_39e5e058-6419-4d47-ab41-d051f58065a1",
  "productndc": "85828-443",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "215822",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "10MG",
        "product_no": "001",
        "approval_date": "Jan 28, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "20MG",
        "product_no": "002",
        "approval_date": "Jan 28, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "FAMOTIDINE",
  "proprietary_name": "Acid Reducer",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA215822",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Famotidine 20mg",
  "start_marketing_date": "20260320",
  "active_numerator_strength": "20"
}

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