Ibuprofen

Orange BookUNIISPLATC G02CC01

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

Identification

ManufacturerPreferred Pharmaceuticals Inc.

CountryUS (United States)

ATC codeG02CC01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 9

ndc11
6878887541
100 TABLET, FILM COATED in 1 BOTTLE (68788-8754-1)
ndc11
6878887542
20 TABLET, FILM COATED in 1 BOTTLE (68788-8754-2)
ndc11
6878887543
30 TABLET, FILM COATED in 1 BOTTLE (68788-8754-3)
ndc11
6878887544
14 TABLET, FILM COATED in 1 BOTTLE (68788-8754-4)
ndc11
6878887545
50 TABLET, FILM COATED in 1 BOTTLE (68788-8754-5)
ndc11
6878887546
60 TABLET, FILM COATED in 1 BOTTLE (68788-8754-6)
ndc11
6878887547
21 TABLET, FILM COATED in 1 BOTTLE (68788-8754-7)
ndc11
6878887548
120 TABLET, FILM COATED in 1 BOTTLE (68788-8754-8)
ndc11
6878887549
90 TABLET, FILM COATED in 1 BOTTLE (68788-8754-9)

Annotations

UNII (FDA Substance ID)

WK2XYI10QM

IBUPROFEN

RxCUI 5640

Orange Book

A202413

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": "68788-8754_60c0958f-f255-410c-ba26-3b819475064c",
  "productndc": "68788-8754",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "202413",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "001",
        "approval_date": "Nov 23, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "600MG",
        "product_no": "002",
        "approval_date": "Nov 23, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "800MG",
        "product_no": "003",
        "approval_date": "Nov 23, 2016"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "300MG",
        "product_no": "004",
        "approval_date": "Jul 5, 2024"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IBUPROFEN",
  "proprietary_name": "Ibuprofen",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA202413",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen",
  "start_marketing_date": "20241014",
  "active_numerator_strength": "600"
}

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