Ibuprofen and famotidine

Orange BookUNIISPLATC A02BA

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerAdvanced Rx of Tennessee, LLC

CountryUS (United States)

ATC codeA02BA

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
8042504831
30 TABLET in 1 BOTTLE (80425-0483-1)
ndc11
8042504832
60 TABLET in 1 BOTTLE (80425-0483-2)
ndc11
8042504833
90 TABLET in 1 BOTTLE (80425-0483-3)

Annotations

UNII (FDA Substance ID)

5QZO15J2Z8

FAMOTIDINE

RxCUI 4278

Orange Book

A203658

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": "80425-0483_2cf74136-002a-d2a4-e063-6294a90ae545",
  "productndc": "80425-0483",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "203658",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "26.6MG;800MG",
        "product_no": "001",
        "approval_date": "Mar 22, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FAMOTIDINE; IBUPROFEN",
  "proprietary_name": "Ibuprofen and famotidine",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA203658",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen and famotidine",
  "start_marketing_date": "20240322",
  "active_numerator_strength": "26.6; 800"
}

Related drugs

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