NDC 55292-122

NeoProfen

Ibuprofen Lysine

NeoProfen is a Intravenous Solution in the Human Prescription Drug category. It is labeled and distributed by Recordati Rare Diseases, Inc.. The primary component is Ibuprofen Lysine.

Product ID55292-122_094d15fb-6d3e-4ab9-9476-89ae9970fb9e
NDC55292-122
Product TypeHuman Prescription Drug
Proprietary NameNeoProfen
Generic NameIbuprofen Lysine
Dosage FormSolution
Route of AdministrationINTRAVENOUS
Marketing Start Date2006-04-13
Marketing CategoryNDA / NDA
Application NumberNDA021903
Labeler NameRECORDATI RARE DISEASES, INC.
Substance NameIBUPROFEN LYSINE
Active Ingredient Strength10 mg/mL
Pharm ClassesCyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 55292-122-52

3 VIAL in 1 CARTON (55292-122-52) > 2 mL in 1 VIAL
Marketing Start Date2006-04-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55292-122-52 [55292012252]

NeoProfen SOLUTION
Marketing CategoryNDA
Application NumberNDA021903
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2006-04-13

Drug Details

Active Ingredients

IngredientStrength
IBUPROFEN LYSINE10 mg/mL

OpenFDA Data

SPL SET ID:6f5ede6f-b0b7-4fc8-969e-652f60ead047
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 637197
  • 1747294
  • UPC Code
  • 0355292122528
  • Pharmacological Class

    • Cyclooxygenase Inhibitors [MoA]
    • Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
    • Nonsteroidal Anti-inflammatory Drug [EPC]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]
    • Cyclooxygenase Inhibitors [MoA]
    • Anti-Inflammatory Agents
    • Non-Steroidal [CS]
    • Nonsteroidal Anti-inflammatory Drug [EPC]

    NDC Crossover Matching brand name "NeoProfen" or generic name "Ibuprofen Lysine"

    NDCBrand NameGeneric Name
    55292-122NeoProfenibuprofen lysine
    39822-1030Ibuprofen LysineIbuprofen Lysine
    66993-490Ibuprofen Lysineibuprofen lysine

    Trademark Results [NeoProfen]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    NEOPROFEN
    NEOPROFEN
    78435265 3213895 Live/Registered
    RECORDATI RARE DISEASES INC.
    2004-06-15

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