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United States · US · US:68071-3053_1d8e3521-5b6d-3418-e063-6294a90a9c41

IBU

Orange BookUNIISPLATC G02CC01

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

Identification

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

Packs · 5

  • ndc11
    6807130530
    12 TABLET in 1 BOTTLE (68071-3053-0)
  • ndc11
    6807130531
    120 TABLET in 1 BOTTLE (68071-3053-1)
  • ndc11
    6807130532
    20 TABLET in 1 BOTTLE (68071-3053-2)
  • ndc11
    6807130534
    40 TABLET in 1 BOTTLE (68071-3053-4)
  • ndc11
    6807130536
    60 TABLET in 1 BOTTLE (68071-3053-6)

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": {
    "bbf4821d-f9fc-9f6e-e053-2a95a90a5253": {
      "match": "brand_token",
      "title": "IBU (IBUPROFEN) TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]",
      "spl_version": "6",
      "published_date": "2026-04-29"
    }
  },
  "productid": "68071-3053_1d8e3521-5b6d-3418-e063-6294a90a9c41",
  "productndc": "68071-3053",
  "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": "IBU",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA075682",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen",
  "start_marketing_date": "20081120",
  "active_numerator_strength": "800"
}

Related drugs

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