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 · 10

ndc11
6318798015
15 TABLET, FILM COATED in 1 BOTTLE (63187-980-15)
ndc11
6318798020
20 TABLET, FILM COATED in 1 BOTTLE (63187-980-20)
ndc11
6318798021
21 TABLET, FILM COATED in 1 BOTTLE (63187-980-21)
ndc11
6318798028
28 TABLET, FILM COATED in 1 BOTTLE (63187-980-28)
ndc11
6318798030
30 TABLET, FILM COATED in 1 BOTTLE (63187-980-30)
ndc11
6318798040
40 TABLET, FILM COATED in 1 BOTTLE (63187-980-40)
ndc11
6318798042
42 TABLET, FILM COATED in 1 BOTTLE (63187-980-42)
ndc11
6318798050
50 TABLET, FILM COATED in 1 BOTTLE (63187-980-50)
ndc11
6318798060
60 TABLET, FILM COATED in 1 BOTTLE (63187-980-60)
ndc11
6318798090
90 TABLET, FILM COATED in 1 BOTTLE (63187-980-90)

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": "63187-980_35ff4860-111c-48cb-94c3-6601d892901a",
  "productndc": "63187-980",
  "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": "Ibuprofen",
  "start_marketing_date": "20151221",
  "active_numerator_strength": "600"
}

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