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United States · US · US:67296-0913_3251a7a8-7561-cf22-e063-6394a90adcb3

IBU

Orange BookUNIISPLATC G02CC01

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

Identification

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

Packs · 3

  • ndc11
    6729609131
    30 TABLET in 1 BOTTLE (67296-0913-1)
  • ndc11
    6729609133
    10 TABLET in 1 BOTTLE (67296-0913-3)
  • ndc11
    6729609139
    90 TABLET in 1 BOTTLE (67296-0913-9)

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": {
    "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": "67296-0913_3251a7a8-7561-cf22-e063-6394a90adcb3",
  "productndc": "67296-0913",
  "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": "IBU",
  "start_marketing_date": "20081120",
  "active_numerator_strength": "600"
}

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