Ibuprofen

Orange BookUNIISPLATC G02CC01

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

Identification

ManufacturerDirect_Rx

CountryUS (United States)

ATC codeG02CC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 8

ndc11
7218955620
20 TABLET in 1 BOTTLE (72189-556-20)
ndc11
7218955621
21 TABLET in 1 BOTTLE (72189-556-21)
ndc11
7218955630
30 TABLET in 1 BOTTLE (72189-556-30)
ndc11
7218955640
40 TABLET in 1 BOTTLE (72189-556-40)
ndc11
7218955645
45 TABLET in 1 BOTTLE (72189-556-45)
ndc11
7218955660
60 TABLET in 1 BOTTLE (72189-556-60)
ndc11
7218955671
100 TABLET in 1 BOTTLE (72189-556-71)
ndc11
7218955690
90 TABLET in 1 BOTTLE (72189-556-90)

Annotations

UNII (FDA Substance ID)

WK2XYI10QM

IBUPROFEN

RxCUI 5640

Orange Book

A213794

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": "72189-556_4c4c7dc3-d5c8-f3d9-e063-6294a90a426f",
  "productndc": "72189-556",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "213794",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "May 8, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "002",
        "approval_date": "May 8, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "003",
        "approval_date": "May 8, 2020"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "Ibuprofen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA213794",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen",
  "start_marketing_date": "20240611",
  "active_numerator_strength": "800"
}

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