NDC 39822-1030

Ibuprofen Lysine

Ibuprofen Lysine

Ibuprofen Lysine is a Intravenous Solution in the Human Prescription Drug category. It is labeled and distributed by X-gen Pharmaceuticals, Inc.. The primary component is Ibuprofen Lysine.

• Product ID: 39822-1030_1c3d7ae0-7354-46cb-ac78-12e02d8cdd94
• NDC: 39822-1030
• Product Type: Human Prescription Drug
• Proprietary Name: Ibuprofen Lysine
• Generic Name: Ibuprofen Lysine
• Dosage Form: Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2016-04-08
• Marketing Category: ANDA / ANDA
• Application Number: ANDA202402
• Labeler Name: X-GEN Pharmaceuticals, 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: 2020-12-31

Packaging

NDC 39822-1030-2

3 VIAL in 1 CARTON (39822-1030-2) > 2 mL in 1 VIAL (39822-1030-1)

• Marketing Start Date: 2016-04-08
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 39822-1030-2 [39822103002]

Ibuprofen Lysine SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA202402
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-04-08

NDC 39822-1030-1 [39822103001]

Ibuprofen Lysine SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA202402
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-04-08

Drug Details

Active Ingredients

Ingredient	Strength
IBUPROFEN LYSINE	10 mg/mL

OpenFDA Data

• SPL SET ID: 6cfdec66-9483-4abe-98d3-3a7d389cc952
• Manufacturer:
  • X-GEN Pharmaceuticals, Inc.
• UNII:
  • N01ORX9D6S
• RxNorm Concept Unique ID - RxCUI:
  • 1747294
• UPC Code:
  • 0339822019014

Pharmacological Class

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

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

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