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United States · US · US:72205-233_21953598-e7ec-45c2-8fca-05550a1ddf38

FAMOTIDINE

Orange BookUNIISPLATC A02BA03

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

Identification

ManufacturerNovadoz Pharmaceuticals LLC
CountryUS (United States)
ATC codeA02BA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7220523384
    55 mL in 1 BOTTLE (72205-233-84)

Annotations

UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
A219863
AB
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": {
    "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": "72205-233_21953598-e7ec-45c2-8fca-05550a1ddf38",
  "productndc": "72205-233",
  "dosage_form": "POWDER, FOR SUSPENSION",
  "orange_book": {
    "appl_no": "219863",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG/5ML",
        "product_no": "001",
        "approval_date": "Jul 24, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FAMOTIDINE",
  "proprietary_name": "FAMOTIDINE",
  "active_ingred_unit": "mg/5mL",
  "application_number": "ANDA219863",
  "marketing_category": "ANDA",
  "nonproprietary_name": "FAMOTIDINE",
  "start_marketing_date": "20250724",
  "active_numerator_strength": "40"
}

Related drugs

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