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United States · US · US:71205-604_f49b4e82-120c-4012-b4b3-78c0f89ae8fd

IBU

Orange BookUNIISPLATC G02CC01

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeG02CC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 7

  • ndc11
    7120560415
    15 TABLET in 1 BOTTLE (71205-604-15)
  • ndc11
    7120560420
    20 TABLET in 1 BOTTLE (71205-604-20)
  • ndc11
    7120560421
    21 TABLET in 1 BOTTLE (71205-604-21)
  • ndc11
    7120560430
    30 TABLET in 1 BOTTLE (71205-604-30)
  • ndc11
    7120560440
    40 TABLET in 1 BOTTLE (71205-604-40)
  • ndc11
    7120560460
    60 TABLET in 1 BOTTLE (71205-604-60)
  • ndc11
    7120560490
    90 TABLET in 1 BOTTLE (71205-604-90)

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": "71205-604_f49b4e82-120c-4012-b4b3-78c0f89ae8fd",
  "productndc": "71205-604",
  "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": "400"
}

Related drugs

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