NDC 51655-022

OMEPRAZOLE DR

Omeprazole Dr

OMEPRAZOLE DR is a Oral Capsule, Delayed Release in the Human Prescription Drug category. It is labeled and distributed by Northwind Pharmaceuticals, Llc. The primary component is Omeprazole.

• Product ID: 51655-022_ed3d5067-3b30-45fc-a813-791eda993b5e
• NDC: 51655-022
• Product Type: Human Prescription Drug
• Proprietary Name: OMEPRAZOLE DR
• Generic Name: Omeprazole Dr
• Dosage Form: Capsule, Delayed Release
• Route of Administration: ORAL
• Marketing Start Date: 2014-10-27
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076048
• Labeler Name: Northwind Pharmaceuticals, LLC
• Substance Name: OMEPRAZOLE
• Active Ingredient Strength: 20 mg/1
• Pharm Classes: Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 51655-022-25

60 CAPSULE, DELAYED RELEASE in 1 BOTTLE, DISPENSING (51655-022-25)

• Marketing Start Date: 2014-10-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51655-022-25 [51655002225]

OMEPRAZOLE DR CAPSULE, DELAYED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA076048
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-06-09
• Inactivation Date: 2020-01-31

NDC 51655-022-26 [51655002226]

OMEPRAZOLE DR CAPSULE, DELAYED RELEASE

• Marketing Category: ANDA
• Application Number: ANDA076048
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-10-27
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
OMEPRAZOLE	20 mg/1

OpenFDA Data

• SPL SET ID: 78a623e8-47be-44b6-b7e0-5b13b2bcecf9
• Manufacturer:
  • Northwind Pharmaceuticals, LLC
• UNII:
  • KG60484QX9
• RxNorm Concept Unique ID - RxCUI:
  • 198051

Pharmacological Class

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

NDC Crossover Matching brand name "OMEPRAZOLE DR" or generic name "Omeprazole Dr"

NDC	Brand Name	Generic Name
61919-176	OMEPRAZOLE DR	OMEPRAZOLE DR
61919-773	OMEPRAZOLE DR	OMEPRAZOLE DR
61919-807	OMEPRAZOLE DR	OMEPRAZOLE DR
51655-022	OMEPRAZOLE	OMEPRAZOLE DR