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United States · US · US:68788-8438_212b5f4e-a83c-42a3-8b0d-ff0ce269b4c8

Ibuprofen

Orange BookUNIISPLATC G02CC01

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

Identification

ManufacturerPreferred Pharmaceuticals Inc.
CountryUS (United States)
ATC codeG02CC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 7

  • ndc11
    6878884381
    100 TABLET in 1 BOTTLE (68788-8438-1)
  • ndc11
    6878884382
    20 TABLET in 1 BOTTLE (68788-8438-2)
  • ndc11
    6878884383
    30 TABLET in 1 BOTTLE (68788-8438-3)
  • ndc11
    6878884385
    50 TABLET in 1 BOTTLE (68788-8438-5)
  • ndc11
    6878884386
    60 TABLET in 1 BOTTLE (68788-8438-6)
  • ndc11
    6878884388
    28 TABLET in 1 BOTTLE (68788-8438-8)
  • ndc11
    6878884389
    90 TABLET in 1 BOTTLE (68788-8438-9)

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": "68788-8438_212b5f4e-a83c-42a3-8b0d-ff0ce269b4c8",
  "productndc": "68788-8438",
  "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": "20230428",
  "active_numerator_strength": "400"
}

Related drugs

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