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United States · US · US:50090-5446_3d7a2f69-acb6-4040-9cd4-519fa5a20067

Ibuprofen

Orange BookUNIISPLATC G02CC01

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeG02CC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 8

  • ndc11
    5009054460
    10 TABLET in 1 BOTTLE (50090-5446-0)
  • ndc11
    5009054462
    30 TABLET in 1 BOTTLE (50090-5446-2)
  • ndc11
    5009054463
    45 TABLET in 1 BOTTLE (50090-5446-3)
  • ndc11
    5009054464
    60 TABLET in 1 BOTTLE (50090-5446-4)
  • ndc11
    5009054465
    100 TABLET in 1 BOTTLE (50090-5446-5)
  • ndc11
    5009054467
    21 TABLET in 1 BOTTLE (50090-5446-7)
  • ndc11
    5009054468
    12 TABLET in 1 BOTTLE (50090-5446-8)
  • ndc11
    5009054469
    40 TABLET in 1 BOTTLE (50090-5446-9)

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A213794
ABABAB
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": "50090-5446_3d7a2f69-acb6-4040-9cd4-519fa5a20067",
  "productndc": "50090-5446",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "213794",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "May 8, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "002",
        "approval_date": "May 8, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "003",
        "approval_date": "May 8, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "Ibuprofen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213794",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen",
  "start_marketing_date": "20200508",
  "active_numerator_strength": "800"
}

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