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 ID: 55292-122_094d15fb-6d3e-4ab9-9476-89ae9970fb9e
• NDC: 55292-122
• Product Type: Human Prescription Drug
• Proprietary Name: NeoProfen
• Generic Name: Ibuprofen Lysine
• Dosage Form: Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2006-04-13
• Marketing Category: NDA / NDA
• Application Number: NDA021903
• Labeler Name: RECORDATI RARE DISEASES, INC.
• Substance Name: IBUPROFEN LYSINE
• Active Ingredient Strength: 10 mg/mL
• Pharm Classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 55292-122-52

3 VIAL in 1 CARTON (55292-122-52) > 2 mL in 1 VIAL

• Marketing Start Date: 2006-04-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55292-122-52 [55292012252]

NeoProfen SOLUTION

• Marketing Category: NDA
• Application Number: NDA021903
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2006-04-13

Drug Details

Active Ingredients

Ingredient	Strength
IBUPROFEN LYSINE	10 mg/mL

OpenFDA Data

• SPL SET ID: 6f5ede6f-b0b7-4fc8-969e-652f60ead047
• Manufacturer:
  • RECORDATI RARE DISEASES, INC.
• UNII:
  • N01ORX9D6S
• 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"

NDC	Brand Name	Generic Name
55292-122	NeoProfen	ibuprofen lysine
39822-1030	Ibuprofen Lysine	Ibuprofen Lysine
66993-490	Ibuprofen Lysine	ibuprofen lysine