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
6191946315
15 TABLET, FILM COATED in 1 BOTTLE (61919-463-15)
ndc11
6191946321
21 TABLET, FILM COATED in 1 BOTTLE (61919-463-21)
ndc11
6191946340
40 TABLET, FILM COATED in 1 BOTTLE (61919-463-40)
ndc11
6191946345
45 TABLET, FILM COATED in 1 BOTTLE (61919-463-45)
ndc11
6191946360
60 TABLET, FILM COATED in 1 BOTTLE (61919-463-60)
ndc11
6191946371
100 TABLET, FILM COATED in 1 BOTTLE (61919-463-71)
ndc11
6191946372
120 TABLET, FILM COATED in 1 BOTTLE (61919-463-72)
ndc11
6191946390
90 TABLET, FILM COATED in 1 BOTTLE (61919-463-90)

Annotations

UNII (FDA Substance ID)

WK2XYI10QM

IBUPROFEN

RxCUI 5640

Orange Book

A091625

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": "61919-463_4c493c0f-6b6e-a79a-e063-6294a90a982d",
  "productndc": "61919-463",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "091625",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "Sep 15, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "002",
        "approval_date": "Sep 15, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "003",
        "approval_date": "Sep 15, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "IBUPROFEN",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091625",
  "marketing_category": "ANDA",
  "nonproprietary_name": "IBUOROFEN",
  "start_marketing_date": "20190822",
  "active_numerator_strength": "800"
}

Related drugs

Other records sharing ATC code G02CC01.

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