NDC 55150-185

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 Auromedics Pharma Llc. The primary component is Esomeprazole Sodium.

• Product ID: 55150-185_1cc540ab-a7ea-46f1-ab63-86f1251795ed
• NDC: 55150-185
• 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: 2016-08-10
• Marketing Category: ANDA / ANDA
• Application Number: ANDA204657
• Labeler Name: AuroMedics Pharma LLC
• Substance Name: ESOMEPRAZOLE SODIUM
• Active Ingredient Strength: 40 mg/1
• Pharm Classes: Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 55150-185-05

10 VIAL in 1 CARTON (55150-185-05) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

• Marketing Start Date: 2016-08-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55150-185-05 [55150018505]

Esomeprazole Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA204657
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-08-10

Drug Details

Active Ingredients

Ingredient	Strength
ESOMEPRAZOLE SODIUM	40 mg/1

OpenFDA Data

• SPL SET ID: 45a15ba2-2aae-4edc-beaa-4a2357d87f32
• Manufacturer:
  • AuroMedics Pharma LLC
• UNII:
  • L2C9GWQ43H
• RxNorm Concept Unique ID - RxCUI:
  • 486499
  • 486501

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