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United States · US · US:53943-112_352fbff8-a6b2-5f5e-e063-6294a90a25f1

Ibuprofen

Orange BookUNIISPLATC G02CC01

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

Identification

ManufacturerDISCOUNT DRUG MART
CountryUS (United States)
ATC codeG02CC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    5394311202
    1 BOTTLE, PLASTIC in 1 CARTON (53943-112-02) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC
  • ndc11
    5394311203
    1 BOTTLE, PLASTIC in 1 CARTON (53943-112-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC
  • ndc11
    5394311208
    225 TABLET, COATED in 1 BOTTLE, PLASTIC (53943-112-08)

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A202312
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": "53943-112_352fbff8-a6b2-5f5e-e063-6294a90a25f1",
  "productndc": "53943-112",
  "dosage_form": "TABLET, COATED",
  "orange_book": {
    "appl_no": "202312",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Oct 7, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN OTC DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "Ibuprofen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202312",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen",
  "start_marketing_date": "20200301",
  "active_numerator_strength": "200"
}

Related drugs

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