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United States · US · US:54348-830_eaa5b55d-10b0-aab9-e053-2995a90a05d7

Ibuprofen

Orange BookUNIISPLATC G02CC01

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerPharmPak, Inc.
CountryUS (United States)
ATC codeG02CC01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 6

  • ndc11
    5434883000
    1 BOTTLE in 1 BOX (54348-830-00) / 1 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5434883002
    1 BOTTLE in 1 BOX (54348-830-02) / 2 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5434883008
    1 BOTTLE in 1 BOX (54348-830-08) / 8 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5434883010
    1 BOTTLE in 1 BOX (54348-830-10) / 10 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5434883012
    1 BOTTLE in 1 BOX (54348-830-12) / 12 TABLET, FILM COATED in 1 BOTTLE
  • ndc11
    5434883020
    1 BOTTLE in 1 BOX (54348-830-20) / 20 TABLET, FILM COATED in 1 BOTTLE

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": "54348-830_eaa5b55d-10b0-aab9-e053-2995a90a05d7",
  "productndc": "54348-830",
  "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": "20190711",
  "active_numerator_strength": "600"
}

Related drugs

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