NDC 67457-392

Esomeprazole sodium

Esomeprazole Sodium

Esomeprazole sodium is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Esomeprazole Sodium.

• Product ID: 67457-392_3b8d6e09-a4d6-49b7-a32a-101ddd739974
• NDC: 67457-392
• Product Type: Human Prescription Drug
• Proprietary Name: Esomeprazole sodium
• Generic Name: Esomeprazole Sodium
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2018-06-01
• Marketing End Date: 2022-03-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA202686
• Labeler Name: Mylan Institutional LLC
• Substance Name: ESOMEPRAZOLE SODIUM
• Active Ingredient Strength: 40 mg/5mL
• Pharm Classes: Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
• NDC Exclude Flag: N

Packaging

NDC 67457-392-99

10 VIAL in 1 CARTON (67457-392-99) > 5 mL in 1 VIAL

• Marketing Start Date: 2018-06-01
• Marketing End Date: 2022-03-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67457-392-99 [67457039299]

Esomeprazole sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA202686
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-06-01

Drug Details

Active Ingredients

Ingredient	Strength
ESOMEPRAZOLE SODIUM	40 mg/5mL

OpenFDA Data

• SPL SET ID: 3d087eaa-a893-4092-935f-f0019223ce0f
• Manufacturer:
  • Mylan Institutional LLC
• UNII:
  • L2C9GWQ43H
• RxNorm Concept Unique ID - RxCUI:
  • 486499
  • 486501
• UPC Code:
  • 0367457392103
  • 0367457391106

Pharmacological Class

• Proton Pump Inhibitor [EPC]
• Proton Pump Inhibitors [MoA]
• Cytochrome P450 2C19 Inhibitors [MoA]

NDC Crossover Matching brand name "Esomeprazole sodium" or generic name "Esomeprazole Sodium"

NDC	Brand Name	Generic Name
14335-060	Esomeprazole sodium	Esomeprazole sodium
16729-252	Esomeprazole sodium	Esomeprazole sodium
17478-850	Esomeprazole Sodium	Esomeprazole Sodium
55150-184	Esomeprazole Sodium	Esomeprazole Sodium
55150-185	Esomeprazole Sodium	Esomeprazole Sodium
62756-508	Esomeprazole Sodium	Esomeprazole Sodium
62756-509	Esomeprazole Sodium	Esomeprazole Sodium
67457-392	Esomeprazole sodium	Esomeprazole sodium
68083-451	Esomeprazole Sodium	Esomeprazole Sodium
68083-452	Esomeprazole Sodium	Esomeprazole Sodium
70436-190	Esomeprazole sodium	Esomeprazole sodium
0186-6020	NEXIUM	Esomeprazole sodium
0186-6040	NEXIUM	Esomeprazole sodium