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United States · US · US:50844-292_310ac7c5-2530-4013-9f56-934a58054bd1

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 · 10

  • ndc11
    5084429200
    250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-292-00)
  • ndc11
    5084429201
    1 BOTTLE, PLASTIC in 1 CARTON (50844-292-01) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    5084429202
    1 BOTTLE, PLASTIC in 1 CARTON (50844-292-02) / 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    5084429208
    1 BOTTLE, PLASTIC in 1 CARTON (50844-292-08) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    5084429211
    1 BOTTLE, PLASTIC in 1 CARTON (50844-292-11) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    5084429212
    1 BOTTLE, PLASTIC in 1 CARTON (50844-292-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    5084429213
    1 BOTTLE, PLASTIC in 1 CARTON (50844-292-13) / 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    5084429214
    500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-292-14)
  • ndc11
    5084429215
    1 BOTTLE, PLASTIC in 1 CARTON (50844-292-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • ndc11
    5084429216
    1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50844-292-16)

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": "50844-292_310ac7c5-2530-4013-9f56-934a58054bd1",
  "productndc": "50844-292",
  "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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