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 · 7

ndc11
7218926615
15 TABLET, FILM COATED in 1 BOTTLE (72189-266-15)
ndc11
7218926630
30 TABLET, FILM COATED in 1 BOTTLE (72189-266-30)
ndc11
7218926640
40 TABLET, FILM COATED in 1 BOTTLE (72189-266-40)
ndc11
7218926660
60 TABLET, FILM COATED in 1 BOTTLE (72189-266-60)
ndc11
7218926671
100 TABLET, FILM COATED in 1 BOTTLE (72189-266-71)
ndc11
7218926672
120 TABLET, FILM COATED in 1 BOTTLE (72189-266-72)
ndc11
7218926690
90 TABLET, FILM COATED in 1 BOTTLE (72189-266-90)

Annotations

UNII (FDA Substance ID)

WK2XYI10QM

IBUPROFEN

RxCUI 5640

Orange Book

A090796

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": "72189-266_2c285455-94b8-8154-e063-6394a90a0e8c",
  "productndc": "72189-266",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "090796",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "Dec 21, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "002",
        "approval_date": "Dec 21, 2010"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "003",
        "approval_date": "Dec 21, 2010"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "IBUPROFEN",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA090796",
  "marketing_category": "ANDA",
  "nonproprietary_name": "IBUPROFEN",
  "start_marketing_date": "20210916",
  "active_numerator_strength": "800"
}

Related drugs

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