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United States · US · US:55292-122_5b563933-e1a3-418c-a1fd-0433d1d9233f

NEOPROFEN

Orange BookUNIISPLATC C01EB

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

Identification

ManufacturerRecordati Rare Diseases Inc.
CountryUS (United States)
ATC codeC01EB
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5529212252
    3 VIAL in 1 CARTON (55292-122-52) / 2 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
N01ORX9D6S
IBUPROFEN LYSINE
RxCUI 36761
Orange Book
N021903
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": {
    "6f5ede6f-b0b7-4fc8-969e-652f60ead047": {
      "match": "brand_token",
      "title": "NEOPROFEN (IBUPROFEN LYSINE) SOLUTION [RECORDATI RARE DISEASES INC.]",
      "spl_version": "17",
      "published_date": "2024-10-17"
    }
  },
  "productid": "55292-122_5b563933-e1a3-418c-a1fd-0433d1d9233f",
  "productndc": "55292-122",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "021903",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AP",
        "strength": "EQ 20MG BASE/2ML (EQ 10MG BASE/ML)",
        "product_no": "001",
        "approval_date": "Apr 13, 2006"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "IBUPROFEN LYSINE",
  "proprietary_name": "NEOPROFEN",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA021903",
  "marketing_category": "NDA",
  "nonproprietary_name": "ibuprofen lysine",
  "start_marketing_date": "20060413",
  "active_numerator_strength": "10"
}

Related drugs

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