Ibuprofen

Orange BookUNIISPLATC G02CC01

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerProficient Rx LP

CountryUS (United States)

ATC codeG02CC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 6

ndc11
8280422715
15 TABLET, FILM COATED in 1 BOTTLE (82804-227-15)
ndc11
8280422720
20 TABLET, FILM COATED in 1 BOTTLE (82804-227-20)
ndc11
8280422721
21 TABLET, FILM COATED in 1 BOTTLE (82804-227-21)
ndc11
8280422730
30 TABLET, FILM COATED in 1 BOTTLE (82804-227-30)
ndc11
8280422760
60 TABLET, FILM COATED in 1 BOTTLE (82804-227-60)
ndc11
8280422790
90 TABLET, FILM COATED in 1 BOTTLE (82804-227-90)

Annotations

UNII (FDA Substance ID)

WK2XYI10QM

IBUPROFEN

RxCUI 5640

Orange Book

A202413

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": "82804-227_67101108-a41f-4be1-8160-6a817c4c301e",
  "productndc": "82804-227",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "202413",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "Nov 23, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "002",
        "approval_date": "Nov 23, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "003",
        "approval_date": "Nov 23, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "300MG",
        "product_no": "004",
        "approval_date": "Jul 5, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "Ibuprofen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202413",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen",
  "start_marketing_date": "20240523",
  "active_numerator_strength": "800"
}

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