NDC 17478-850

Esomeprazole Sodium

Esomeprazole Sodium

Esomeprazole Sodium is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Akorn, Inc.. The primary component is Esomeprazole Sodium.

• Product ID: 17478-850_0c274901-7308-47c6-9ec0-15cec94fd852
• NDC: 17478-850
• Product Type: Human Prescription Drug
• Proprietary Name: Esomeprazole Sodium
• Generic Name: Esomeprazole Sodium
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-03-06
• Marketing Category: ANDA / ANDA
• Application Number: ANDA207181
• Labeler Name: Akorn, Inc.
• 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
• Listing Certified Through: 2020-12-31

Packaging

NDC 17478-850-10

10 VIAL, SINGLE-DOSE in 1 CARTON (17478-850-10) > 5 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2017-03-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 17478-850-10 [17478085010]

Esomeprazole Sodium INJECTION

• Marketing Category: ANDA
• Application Number: ANDA207181
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-03-06

Drug Details

Active Ingredients

Ingredient	Strength
ESOMEPRAZOLE SODIUM	40 mg/5mL

OpenFDA Data

• SPL SET ID: 27d8e920-932c-4ccb-9ad8-9c7b9e2e4385
• Manufacturer:
  • Akorn, Inc.
• UNII:
  • L2C9GWQ43H
• RxNorm Concept Unique ID - RxCUI:
  • 486501
• UPC Code:
  • 0317478850106

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