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United States · US · US:68788-9110_421ee301-7aef-4484-9572-3eb0c463ef8b

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 · 8

  • ndc11
    6878891101
    100 TABLET in 1 BOTTLE (68788-9110-1)
  • ndc11
    6878891102
    20 TABLET in 1 BOTTLE (68788-9110-2)
  • ndc11
    6878891103
    30 TABLET in 1 BOTTLE (68788-9110-3)
  • ndc11
    6878891105
    50 TABLET in 1 BOTTLE (68788-9110-5)
  • ndc11
    6878891106
    60 TABLET in 1 BOTTLE (68788-9110-6)
  • ndc11
    6878891107
    21 TABLET in 1 BOTTLE (68788-9110-7)
  • ndc11
    6878891108
    120 TABLET in 1 BOTTLE (68788-9110-8)
  • ndc11
    6878891109
    90 TABLET in 1 BOTTLE (68788-9110-9)

Annotations

UNII (FDA Substance ID)
WK2XYI10QM
IBUPROFEN
RxCUI 5640
Orange Book
A075682
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": "68788-9110_421ee301-7aef-4484-9572-3eb0c463ef8b",
  "productndc": "68788-9110",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "075682",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "Nov 14, 2001"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "002",
        "approval_date": "Nov 14, 2001"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "003",
        "approval_date": "Nov 14, 2001"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "Ibuprofen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075682",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen",
  "start_marketing_date": "20081120",
  "active_numerator_strength": "400"
}

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