NDC 65162-957

Esomeprazole strontium

Esomeprazole Strontium

Esomeprazole strontium is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Llc. The primary component is Esomeprazole Strontium.

• Product ID: 65162-957_1bd5463a-ed4b-48ac-baab-3c5cf07465cb
• NDC: 65162-957
• Product Type: Human Prescription Drug
• Proprietary Name: Esomeprazole strontium
• Generic Name: Esomeprazole Strontium
• Dosage Form: Capsule, Delayed Release
• Route of Administration: ORAL
• Marketing Start Date: 2013-08-12
• Marketing Category: NDA AUTHORIZED GENERIC / NDA
• Application Number: NDA202342
• Labeler Name: Amneal Pharmaceuticals LLC
• Substance Name: ESOMEPRAZOLE STRONTIUM
• Active Ingredient Strength: 40 mg/1
• 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 65162-957-03

30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65162-957-03)

• Marketing Start Date: 2013-08-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 65162-957-03 [65162095703]

Esomeprazole strontium CAPSULE, DELAYED RELEASE

• Marketing Category: NDA AUTHORIZED GENERIC
• Application Number: NDA202342
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-08-12

Drug Details

Active Ingredients

Ingredient	Strength
ESOMEPRAZOLE STRONTIUM	40 mg/1

OpenFDA Data

• SPL SET ID: 61a5a84e-0194-4f11-91f8-83d7ac404932
• Manufacturer:
  • Amneal Pharmaceuticals of New York, LLC
• UNII:
  • C5N25H3803
• RxNorm Concept Unique ID - RxCUI:
  • 1810789
  • 1810787
• UPC Code:
  • 0365162957037
  • 0365162955033

Pharmacological Class

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

Medicade Reported Pricing

65162095703 ESOMEPRAZOLE DR 49.3 MG CAP

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Esomeprazole strontium" or generic name "Esomeprazole Strontium"

NDC	Brand Name	Generic Name
52246-400	ESOMEPRAZOLE STRONTIUM	esomeprazole strontium
53746-955	Esomeprazole strontium	Esomeprazole strontium
53746-957	Esomeprazole strontium	Esomeprazole strontium
65162-955	Esomeprazole strontium	Esomeprazole strontium
65162-957	Esomeprazole strontium	Esomeprazole strontium
69336-129	Esomeprazole strontium	Esomeprazole strontium
70849-200	ESOMEPRAZOLE STRONTIUM	esomeprazole strontium
70849-400	ESOMEPRAZOLE STRONTIUM	esomeprazole strontium