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United States · US · US:85509-1626_4ee3e858-3e4f-85de-e063-6394a90a21a0

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
    8550916263
    30 TABLET, FILM COATED in 1 BOTTLE (85509-1626-3)
  • ndc11
    8550916266
    60 TABLET, FILM COATED in 1 BOTTLE (85509-1626-6)
  • ndc11
    8550916269
    90 TABLET, FILM COATED in 1 BOTTLE (85509-1626-9)

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": "85509-1626_4ee3e858-3e4f-85de-e063-6394a90a21a0",
  "productndc": "85509-1626",
  "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 and famotidine",
  "active_ingred_unit": "mg/1; mg/1",
  "application_number": "ANDA211890",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen and famotidine",
  "start_marketing_date": "20210804",
  "active_numerator_strength": "26.6; 800"
}

Related drugs

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