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United States · US · US:71610-275_8205e32a-d524-488b-b591-bc4d697896c1

IBU

Orange BookUNIISPLATC G02CC01

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

Identification

ManufacturerAphena Pharma Solutions - Tennessee, LLC
CountryUS (United States)
ATC codeG02CC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7161027560
    90 TABLET in 1 BOTTLE (71610-275-60)
  • ndc11
    7161027580
    180 TABLET in 1 BOTTLE (71610-275-80)
  • ndc11
    7161027592
    270 TABLET in 1 BOTTLE (71610-275-92)

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": "71610-275_8205e32a-d524-488b-b591-bc4d697896c1",
  "productndc": "71610-275",
  "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"
}

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