NDC 66993-490

Ibuprofen Lysine

Ibuprofen Lysine

Ibuprofen Lysine is a Intravenous Solution in the Human Prescription Drug category. It is labeled and distributed by Prasco Laboratories. The primary component is Ibuprofen Lysine.

• Product ID: 66993-490_7c736d84-e1d2-3176-e053-2a91aa0a2c42
• NDC: 66993-490
• Product Type: Human Prescription Drug
• Proprietary Name: Ibuprofen Lysine
• Generic Name: Ibuprofen Lysine
• Dosage Form: Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2016-04-14
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA021903
• Labeler Name: Prasco Laboratories
• 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: 2019-12-31

Packaging

NDC 66993-490-36

3 VIAL in 1 CARTON (66993-490-36) > 2 mL in 1 VIAL

• Marketing Start Date: 2016-04-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 66993-490-36 [66993049036]

Ibuprofen Lysine SOLUTION

• Marketing Category: NDA authorized generic
• Application Number: NDA021903
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2016-04-14

Drug Details

Active Ingredients

Ingredient	Strength
IBUPROFEN LYSINE	10 mg/mL

OpenFDA Data

• SPL SET ID: 307431c7-12de-21e5-e054-00144ff88e88
• Manufacturer:
  • Prasco Laboratories
• UNII:
  • N01ORX9D6S
• RxNorm Concept Unique ID - RxCUI:
  • 1747294

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