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United States · US · US:72189-641_3f16596d-dd5b-7985-e063-6294a90a6f9d

Ibuprofen Famotidine

Orange BookUNIISPLATC A02BA

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

Identification

ManufacturerDirect_Rx
CountryUS (United States)
ATC codeA02BA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7218964190
    90 TABLET, FILM COATED in 1 BOTTLE (72189-641-90)

Annotations

UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
A211890
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": {
    "aeee629b-255c-40d8-8e95-779aec00f723": {
      "match": "brand_token",
      "title": "IBUPROFEN TABLET [NORTHSTAR RX LLC]",
      "spl_version": "1",
      "published_date": "2026-06-02"
    }
  },
  "productid": "72189-641_3f16596d-dd5b-7985-e063-6294a90a6f9d",
  "productndc": "72189-641",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "211890",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "26.6MG;800MG",
        "product_no": "001",
        "approval_date": "Aug 3, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FAMOTIDINE; IBUPROFEN",
  "proprietary_name": "Ibuprofen Famotidine",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA211890",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen Famotidine",
  "start_marketing_date": "20250918",
  "active_numerator_strength": "26.6; 800"
}

Related drugs

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