OMEPRAZOLE

Product NDC: 51655-023
11-digit product format: 516550023
Labeler code: 51655
Product ID: 51655-023_30e7e098-a723-485d-928f-b13f51193b58
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: OMEPRAZOLE
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Northwind Pharmaceuticals, LLC
Application: ANDA076048
Marketing category: ANDA
Marketing start: 2015-02-05
Marketing end: 0000-00-00
Substance: OMEPRAZOLE
Active strength: 40 mg/1
Pharmacologic classes: Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51655-023-26	2026-01-05	C162847	48780-1	9d75b9d1-09e1-f424-e053-dadaa90a57ce	2c40d64b-5e7b-4381-9ebf-df3a4bf0edfe
51655-023-26	2020-01-31	C162847	48780-1	9d75b9d1-09e1-f424-e053-dadaa90a57ce	2c40d64b-5e7b-4381-9ebf-df3a4bf0edfe

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
OMEPRAZOLE	ACTIVE INGREDIENT	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]	1
OMEPRAZOLE	ACTIVE MOIETY	KG60484QX9	OMEPRAZOLE CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]	1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-023	OMEPRAZOLE CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]	1	Legacy NDC	20150325_2c40d64b-5e7b-4381-9ebf-df3a4bf0edfe.zip