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 · 9

ndc11
6318702215
15 TABLET in 1 BOTTLE (63187-022-15)
ndc11
6318702220
20 TABLET in 1 BOTTLE (63187-022-20)
ndc11
6318702221
21 TABLET in 1 BOTTLE (63187-022-21)
ndc11
6318702230
30 TABLET in 1 BOTTLE (63187-022-30)
ndc11
6318702240
40 TABLET in 1 BOTTLE (63187-022-40)
ndc11
6318702245
45 TABLET in 1 BOTTLE (63187-022-45)
ndc11
6318702260
60 TABLET in 1 BOTTLE (63187-022-60)
ndc11
6318702272
120 TABLET in 1 BOTTLE (63187-022-72)
ndc11
6318702290
90 TABLET in 1 BOTTLE (63187-022-90)

Annotations

UNII (FDA Substance ID)

WK2XYI10QM

IBUPROFEN

RxCUI 5640

Orange Book

A078558

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": "63187-022_7db62aa5-dd71-4f62-b656-c4df75686f02",
  "productndc": "63187-022",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "078558",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "Jun 18, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "002",
        "approval_date": "Jun 18, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "003",
        "approval_date": "Jun 18, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "Ibuprofen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078558",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen",
  "start_marketing_date": "20091123",
  "active_numerator_strength": "800"
}

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