Omeprazole Magnesium

Product NDC
59450-012
11-digit product format
594500012
Labeler code
59450
Product ID
59450-012_272675b2-9db3-9e39-affe-6723b3ede96e
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole Magnesium 20.6mg Capsules
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
The Kroger Co.
Application
ANDA078878
Marketing category
ANDA
Marketing start
2016-01-01
Marketing end
0000-00-00
Substance
OMEPRAZOLE MAGNESIUM
Active strength
20 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLE MAGNESIUMACTIVE INGREDIENT426QFE7XLKOMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]2
omeprazoleACTIVE MOIETYKG60484QX9OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]2
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JOMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]2
CARRAGEENANINACTIVE INGREDIENT5C69YCD2YJOMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]2
HYPROMELLOSE 2208 (3 MPA.S)INACTIVE INGREDIENT9H4L916OBUOMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]2
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71GOMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JOMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]2
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:2)INACTIVE INGREDIENT5KY68S2577OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]2
POTASSIUM CHLORIDEINACTIVE INGREDIENT660YQ98I10OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TOMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]2
RAW SUGARINACTIVE INGREDIENT8M707QY5GHOMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]2
SHELLACINACTIVE INGREDIENT46N107B71OOMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]2
TALCINACTIVE INGREDIENT7SEV7J4R1UOMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59450-012OMEPRAZOLE MAGNESIUM (OMEPRAZOLE MAGNESIUM 20.6MG CAPSULES) CAPSULE, DELAYED RELEASE [THE KROGER CO.]6Legacy NDC20241218_c962c55e-3699-511b-eb16-5da8b47fd0a2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59450-012-01594500012013 BOTTLE in 1 CARTON (59450-012-01) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2016-01-010000-00-00NoNoCurrent
59450-012-27594500012272 BOTTLE in 1 CARTON (59450-012-27) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2016-01-010000-00-00NoNoCurrent