FDA.reportPublic FDA data

OMEPRAZOLE

Product NDC
51655-022
11-digit product format
516550022
Labeler code
51655
Product ID
51655-022_ed3d5067-3b30-45fc-a813-791eda993b5e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OMEPRAZOLE DR
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Northwind Pharmaceuticals, LLC
Application
ANDA076048
Marketing category
ANDA
Marketing start
2014-10-27
Marketing end
0000-00-00
Substance
OMEPRAZOLE
Active strength
20 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
NDCEffectiveActionDocumentIndexing SPLRelated label
51655-022-252026-01-05C16284748780-19d75b9d0-f6e2-f424-e053-dadaa90a57ce78a623e8-47be-44b6-b7e0-5b13b2bcecf9
51655-022-262026-01-05C16284748780-19d75b9d0-f6e2-f424-e053-dadaa90a57ce78a623e8-47be-44b6-b7e0-5b13b2bcecf9
51655-022-252020-01-31C16284748780-19d75b9d0-f6e2-f424-e053-dadaa90a57ce78a623e8-47be-44b6-b7e0-5b13b2bcecf9
51655-022-262020-01-31C16284748780-19d75b9d0-f6e2-f424-e053-dadaa90a57ce78a623e8-47be-44b6-b7e0-5b13b2bcecf9

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]2
OMEPRAZOLEACTIVE MOIETYKG60484QX9OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]2
GELATININACTIVE INGREDIENT2G86QN327LOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]2
MAGNESIUM HYDROXIDEINACTIVE INGREDIENTNBZ3QY004SOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]2
SHELLACINACTIVE INGREDIENT46N107B71OOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-022OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [NORTHWIND PHARMACEUTICALS, LLC]2Legacy NDC20150609_78a623e8-47be-44b6-b7e0-5b13b2bcecf9.zip