NDC 68083-452

Esomeprazole Sodium

Esomeprazole Sodium

Esomeprazole Sodium is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Esomeprazole Sodium.

• Product ID: 68083-452_587c4f14-9800-4d26-9bc7-51a1abebaa5d
• NDC: 68083-452
• Product Type: Human Prescription Drug
• Proprietary Name: Esomeprazole Sodium
• Generic Name: Esomeprazole Sodium
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2020-04-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203349
• Labeler Name: Gland Pharma Limited
• Substance Name: ESOMEPRAZOLE SODIUM
• Active Ingredient Strength: 40 mg/5mL
• 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 68083-452-10

10 VIAL in 1 CARTON (68083-452-10) > 5 mL in 1 VIAL (68083-452-01)

• Marketing Start Date: 2020-04-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68083-452-10 [68083045210]

Esomeprazole Sodium INJECTION

• Marketing Category: ANDA
• Application Number: ANDA203349
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-04-01

NDC 68083-452-01 [68083045201]

Esomeprazole Sodium INJECTION

• Marketing Category: ANDA
• Application Number: ANDA203349
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-04-01

Drug Details

Active Ingredients

Ingredient	Strength
ESOMEPRAZOLE SODIUM	40 mg/5mL

OpenFDA Data

• SPL SET ID: 9354958c-e997-41c8-8605-23f0a58993c0
• Manufacturer:
  • Gland Pharma Limited
• UNII:
  • L2C9GWQ43H
• RxNorm Concept Unique ID - RxCUI:
  • 486499
  • 486501
• UPC Code:
  • 0368083452100

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