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United States · US · US:50844-392_3598e956-6088-45ba-a7ea-9500e00291c3

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 · 7

  • ndc11
    5084439202
    1 BOTTLE, PLASTIC in 1 CARTON (50844-392-02) / 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    5084439208
    1 BOTTLE, PLASTIC in 1 CARTON (50844-392-08) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    5084439212
    1 BOTTLE, PLASTIC in 1 CARTON (50844-392-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    5084439214
    500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-392-14)
  • ndc11
    5084439215
    1 BOTTLE, PLASTIC in 1 CARTON (50844-392-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    5084439216
    1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-392-16)
  • ndc11
    5084439250
    50 POUCH in 1 CARTON (50844-392-50) / 2 TABLET, FILM COATED in 1 POUCH (50844-392-24)

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A075139
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": "50844-392_3598e956-6088-45ba-a7ea-9500e00291c3",
  "productndc": "50844-392",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "075139",
    "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": "ANDA075139",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ibuprofen",
  "start_marketing_date": "19990301",
  "active_numerator_strength": "200"
}

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