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United States · US · US:68788-8531_0b5c32bc-2bff-491d-910b-7921c3395ef8

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 · 9

  • ndc11
    6878885311
    100 TABLET, FILM COATED in 1 BOTTLE (68788-8531-1)
  • ndc11
    6878885312
    20 TABLET, FILM COATED in 1 BOTTLE (68788-8531-2)
  • ndc11
    6878885313
    30 TABLET, FILM COATED in 1 BOTTLE (68788-8531-3)
  • ndc11
    6878885314
    14 TABLET, FILM COATED in 1 BOTTLE (68788-8531-4)
  • ndc11
    6878885315
    50 TABLET, FILM COATED in 1 BOTTLE (68788-8531-5)
  • ndc11
    6878885316
    60 TABLET, FILM COATED in 1 BOTTLE (68788-8531-6)
  • ndc11
    6878885317
    21 TABLET, FILM COATED in 1 BOTTLE (68788-8531-7)
  • ndc11
    6878885318
    120 TABLET, FILM COATED in 1 BOTTLE (68788-8531-8)
  • ndc11
    6878885319
    90 TABLET, FILM COATED in 1 BOTTLE (68788-8531-9)

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A078329
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": "68788-8531_0b5c32bc-2bff-491d-910b-7921c3395ef8",
  "productndc": "68788-8531",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "078329",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "Feb 5, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "002",
        "approval_date": "Feb 5, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "003",
        "approval_date": "Feb 5, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "Ibuprofen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078329",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen",
  "start_marketing_date": "20231006",
  "active_numerator_strength": "600"
}

Related drugs

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