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United States · US · US:55319-252_507df8d5-42bb-4c21-b28e-4b40e48879d0

Ibuprofen

Orange BookUNIISPLATC G02CC01

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

Identification

ManufacturerFamily Dollar (FAMILY WELLNESS)
CountryUS (United States)
ATC codeG02CC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 5

  • ndc11
    5531925205
    500 TABLET, COATED in 1 BOTTLE (55319-252-05)
  • ndc11
    5531925210
    1 BOTTLE, PLASTIC in 1 BOX (55319-252-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC
  • ndc11
    5531925224
    1 BOTTLE, PLASTIC in 1 BOX (55319-252-24) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC
  • ndc11
    5531925225
    1 BOTTLE, PLASTIC in 1 BOX (55319-252-25) / 250 TABLET, COATED in 1 BOTTLE, PLASTIC
  • ndc11
    5531925250
    1 BOTTLE, PLASTIC in 1 BOX (55319-252-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A079129
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": "55319-252_507df8d5-42bb-4c21-b28e-4b40e48879d0",
  "productndc": "55319-252",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "079129",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Mar 28, 2011"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "Ibuprofen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA079129",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen",
  "start_marketing_date": "20230915",
  "active_numerator_strength": "200"
}

Related drugs

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