NDC 62756-509

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 Sun Pharmaceutical Industries Limited. The primary component is Esomeprazole Sodium.

• Product ID: 62756-509_c1aee218-5681-4f2e-9fd5-c356b0f81e41
• NDC: 62756-509
• 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: 2014-12-15
• Marketing Category: ANDA / ANDA
• Application Number: ANDA200882
• Labeler Name: Sun Pharmaceutical Industries Limited
• 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: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 62756-509-44

10 VIAL, SINGLE-USE in 1 CARTON (62756-509-44) > 5 mL in 1 VIAL, SINGLE-USE (62756-509-40)

• Marketing Start Date: 2014-12-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 62756-509-44 [62756050944]

Esomeprazole Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA200882
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-12-15
• Marketing End Date: 2016-07-31

NDC 62756-509-40 [62756050940]

Esomeprazole Sodium INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA200882
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2014-12-15
• Marketing End Date: 2016-07-31

Drug Details

Active Ingredients

Ingredient	Strength
ESOMEPRAZOLE SODIUM	40 mg/5mL

OpenFDA Data

• SPL SET ID: 6522751a-b188-4117-b6b9-5b2d120f2c83
• Manufacturer:
  • Sun Pharmaceutical Industries Limited
• 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