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United States · US · US:68071-3413_2d6c6f77-6942-4cd6-e063-6294a90a3b62

FAMOTIDINE

Orange BookUNIISPLATC A02BA03

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

Identification

ManufacturerNuCare Pharmceuticals,Inc.
CountryUS (United States)
ATC codeA02BA03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6807134133
    30 TABLET, FILM COATED in 1 BOTTLE (68071-3413-3)

Annotations

UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
A215630
ABAB
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": "68071-3413_2d6c6f77-6942-4cd6-e063-6294a90a3b62",
  "productndc": "68071-3413",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "215630",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "20MG",
        "product_no": "001",
        "approval_date": "Jan 7, 2022"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "40MG",
        "product_no": "002",
        "approval_date": "Jan 7, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FAMOTIDINE",
  "proprietary_name": "FAMOTIDINE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA215630",
  "marketing_category": "ANDA",
  "nonproprietary_name": "FAMOTIDINE",
  "start_marketing_date": "20220708",
  "active_numerator_strength": "40"
}

Related drugs

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