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United States · US · US:85786-107_497c7ff4-c338-fd38-e063-6394a90a8874

IBUPROFEN 200 MG

Orange BookUNIISPLATC G02CC01

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

Identification

ManufacturerFarmacias De Similares TX LLC
CountryUS (United States)
ATC codeG02CC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    8578610730
    30 TABLET, COATED in 1 CARTON (85786-107-30)

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A079174
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "WK2XYI10QM",
    "rxcui": "5640",
    "inchikey": "HEFNNWSXXWATRW-UHFFFAOYSA-N",
    "display_name": "IBUPROFEN",
    "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": "85786-107_497c7ff4-c338-fd38-e063-6394a90a8874",
  "productndc": "85786-107",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "079174",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Dec 10, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "IBUPROFEN 200 MG",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA079174",
  "marketing_category": "ANDA",
  "nonproprietary_name": "IBUPROFEN 200 MG",
  "start_marketing_date": "20260101",
  "active_numerator_strength": "200"
}

Related drugs

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