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United States · US · US:83324-056_5c5740ec-021a-4ec2-b6fd-7158a58387a9

Ibuprofen

Orange BookUNIISPLATC G02CC01

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

Identification

ManufacturerChain Drug Marketing Association, Inc.
CountryUS (United States)
ATC codeG02CC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    8332405601
    1 BOTTLE, PLASTIC in 1 CARTON (83324-056-01) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    8332405624
    1 BOTTLE, PLASTIC in 1 CARTON (83324-056-24) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    8332405650
    1 BOTTLE, PLASTIC in 1 CARTON (83324-056-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A075010
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": "83324-056_5c5740ec-021a-4ec2-b6fd-7158a58387a9",
  "productndc": "83324-056",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "075010",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Mar 1, 1999"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "Ibuprofen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075010",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen",
  "start_marketing_date": "20240813",
  "active_numerator_strength": "200"
}

Related drugs

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