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United States · US · US:39822-1030_09c10e65-0cea-3052-e063-6394a90ae199

Ibuprofen Lysine

Orange BookUNIISPLATC C01EB

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

Identification

ManufacturerXGen Pharmaceuticals DJB, Inc.
CountryUS (United States)
ATC codeC01EB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    3982210302
    3 VIAL in 1 CARTON (39822-1030-2) / 2 mL in 1 VIAL (39822-1030-1)

Annotations

UNII (FDA Substance ID)
N01ORX9D6S
IBUPROFEN LYSINE
RxCUI 36761
Orange Book
A202402
AP
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "N01ORX9D6S",
    "rxcui": "36761",
    "inchikey": "IHHXIUAEPKVVII-ZSCHJXSPSA-N",
    "display_name": "IBUPROFEN LYSINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "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": "39822-1030_09c10e65-0cea-3052-e063-6394a90ae199",
  "productndc": "39822-1030",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "202402",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 20MG BASE/2ML (EQ 10MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Mar 30, 2016"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IBUPROFEN LYSINE",
  "proprietary_name": "Ibuprofen Lysine",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA202402",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ibuprofen Lysine",
  "start_marketing_date": "20160408",
  "active_numerator_strength": "10"
}

Related drugs

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