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United States · US · US:69168-443_10efebb0-5d63-4c46-8934-9e91b213a543

Acid Reducer

Orange BookUNIISPLATC A02BA03

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

Identification

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

Packs · 5

  • ndc11
    6916844309
    10 TABLET in 1 BLISTER PACK (69168-443-09)
  • ndc11
    6916844332
    100 TABLET in 1 BOTTLE (69168-443-32)
  • ndc11
    6916844350
    1 BOTTLE in 1 CARTON (69168-443-50) / 50 TABLET in 1 BOTTLE
  • ndc11
    6916844352
    225 TABLET in 1 BOTTLE (69168-443-52)
  • ndc11
    6916844399
    365 TABLET in 1 BOTTLE (69168-443-99)

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": "69168-443_10efebb0-5d63-4c46-8934-9e91b213a543",
  "productndc": "69168-443",
  "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",
  "start_marketing_date": "20240115",
  "active_numerator_strength": "20"
}

Related drugs

Other records sharing ATC code A02BA03.

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