NDC 70849-400

ESOMEPRAZOLE STRONTIUM

Esomeprazole Strontium

ESOMEPRAZOLE STRONTIUM is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by R2 Pharma, Llc. The primary component is Esomeprazole Strontium.

• Product ID: 70849-400_3d19523d-7cb5-2f2f-e054-00144ff88e88
• NDC: 70849-400
• 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: 2016-09-15
• Marketing Category: NDA / NDA
• Application Number: NDA202342
• Labeler Name: R2 Pharma, 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 70849-400-30

30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70849-400-30)

• Marketing Start Date: 2016-09-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70849-400-30 [70849040030]

ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE

• Marketing Category: NDA
• Application Number: NDA202342
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-09-15

Drug Details

Active Ingredients

Ingredient	Strength
ESOMEPRAZOLE STRONTIUM	40 mg/1

OpenFDA Data

• SPL SET ID: 3c916d32-f9e9-1d15-e054-00144ff88e88
• Manufacturer:
  • R2 Pharma, LLC
• UNII:
  • C5N25H3803
• RxNorm Concept Unique ID - RxCUI:
  • 1810789
  • 1810787
• UPC Code:
  • 0370849400300
  • 0370849200306

Pharmacological Class

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

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