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United States · US · US:43602-544_97d403fb-8a67-483d-8f9c-45dd16a31689

IBUPROFEN AND FAMOTIDINE

Orange BookUNIISPLATC A02BA

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

Identification

ManufacturerAscent Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeA02BA
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    4360254405
    500 TABLET in 1 BOTTLE (43602-544-05)
  • ndc11
    4360254430
    30 TABLET in 1 BOTTLE (43602-544-30)
  • ndc11
    4360254490
    90 TABLET in 1 BOTTLE (43602-544-90)

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": "43602-544_97d403fb-8a67-483d-8f9c-45dd16a31689",
  "productndc": "43602-544",
  "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": "20221006",
  "active_numerator_strength": "26.6; 800"
}

Related drugs

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