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United States · US · US:85509-1315_3ff33409-9785-67bc-e063-6394a90ae2f3

IBUPROFEN AND FAMOTIDINE

Orange BookUNIISPLATC A02BA

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

Identification

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

Packs · 3

  • ndc11
    8550913153
    30 TABLET in 1 BOTTLE (85509-1315-3)
  • ndc11
    8550913156
    60 TABLET in 1 BOTTLE (85509-1315-6)
  • ndc11
    8550913159
    90 TABLET in 1 BOTTLE (85509-1315-9)

Annotations

UNII (FDA Substance ID)
5QZO15J2Z8
FAMOTIDINE
RxCUI 4278
Orange Book
A216814
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": "85509-1315_3ff33409-9785-67bc-e063-6394a90ae2f3",
  "productndc": "85509-1315",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "216814",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "26.6MG;800MG",
        "product_no": "001",
        "approval_date": "Mar 15, 2023"
      }
    ],
    "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": "ANDA216814",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen and famotidine",
  "start_marketing_date": "20230315",
  "active_numerator_strength": "26.6; 800"
}

Related drugs

Other records sharing ATC code A02BA.

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