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United States · US · US:50844-291_beb6ea94-7f3d-4d13-90a5-e717aa719050

Ibuprofen

Orange BookUNIISPLATC G02CC01

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

Identification

ManufacturerL.N.K. International, Inc.
CountryUS (United States)
ATC codeG02CC01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 15

  • ndc11
    5084429101
    1 BOTTLE, PLASTIC in 1 CARTON (50844-291-01) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    5084429102
    1 BOTTLE, PLASTIC in 1 CARTON (50844-291-02) / 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    5084429103
    10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-291-03)
  • ndc11
    5084429108
    1 BOTTLE, PLASTIC in 1 CARTON (50844-291-08) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    5084429110
    1 BOTTLE, PLASTIC in 1 CARTON (50844-291-10) / 40 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    5084429111
    1 BOTTLE, PLASTIC in 1 CARTON (50844-291-11) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    5084429112
    1 BOTTLE, PLASTIC in 1 CARTON (50844-291-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    5084429113
    1 BOTTLE, PLASTIC in 1 CARTON (50844-291-13) / 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    5084429114
    500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-291-14)
  • ndc11
    5084429115
    1 BOTTLE, PLASTIC in 1 CARTON (50844-291-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    5084429116
    1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-291-16)
  • ndc11
    5084429117
    300 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-291-17)
  • ndc11
    5084429129
    1 BOTTLE, PLASTIC in 1 CARTON (50844-291-29) / 150 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    5084429150
    50 POUCH in 1 CARTON (50844-291-50) / 2 TABLET, FILM COATED in 1 POUCH (50844-291-24)
  • ndc11
    5084429199
    250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-291-99)

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": "50844-291_beb6ea94-7f3d-4d13-90a5-e717aa719050",
  "productndc": "50844-291",
  "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": "19880524",
  "active_numerator_strength": "200"
}

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