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United States · US · US:63323-739_7411dc23-e297-42cb-b491-b90d70c841a3

Famotidine

Orange BookUNIISPLATC A02BA03

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

Identification

ManufacturerFresenius Kabi USA, LLC
CountryUS (United States)
ATC codeA02BA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6332373912
    25 VIAL, SINGLE-DOSE in 1 TRAY (63323-739-12) / 2 mL in 1 VIAL, SINGLE-DOSE (63323-739-11)

Annotations

UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
A075813
AP
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": "INTRAVENOUS",
  "spl_meta": {
    "e53928f3-5181-490b-acfb-be8d4cea60a9": {
      "match": "brand_token",
      "title": "FAMOTIDINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]",
      "spl_version": "1",
      "published_date": "2026-06-01"
    }
  },
  "productid": "63323-739_7411dc23-e297-42cb-b491-b90d70c841a3",
  "productndc": "63323-739",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "075813",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "10MG/ML",
        "product_no": "001",
        "approval_date": "Apr 16, 2001"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FAMOTIDINE",
  "proprietary_name": "Famotidine",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA075813",
  "marketing_category": "ANDA",
  "nonproprietary_name": "FAMOTIDINE",
  "start_marketing_date": "20010315",
  "active_numerator_strength": "10"
}

Related drugs

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