Omeprazole Magnesium

Product NDC
41250-064
11-digit product format
412500064
Labeler code
41250
Product ID
41250-064_7e5c4f4f-4ef5-156b-3236-94459e5747ce
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Meijer Distribution Inc
Application
ANDA078878
Marketing category
ANDA
Marketing start
2014-09-22
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 CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC]2
omeprazoleACTIVE MOIETYKG60484QX9OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC]2
Anhydrous Dibasic Calcium PhosphateINACTIVE INGREDIENTL11K75P92JOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC]2
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC]2
Ferrosoferric OxideINACTIVE INGREDIENTXM0M87F357OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC]2
GelatinINACTIVE INGREDIENT2G86QN327LOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC]2
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE4OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC]2
Hypromellose 2208 (3 Mpa.S)INACTIVE INGREDIENT9H4L916OBUOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC]2
Magnesium OxideINACTIVE INGREDIENT3A3U0GI71GOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC]2
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type AINACTIVE INGREDIENTNX76LV5T8JOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC]2
Methacrylic Acid - Methyl Methacrylate Copolymer (1:2)INACTIVE INGREDIENT5KY68S2577OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC]2
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC]2
Potassium HydroxideINACTIVE INGREDIENTWZH3C48M4TOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC]2
RAW SUGARINACTIVE INGREDIENT8M707QY5GHOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC]2
SHELLACINACTIVE INGREDIENT46N107B71OOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC]2
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-064OMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE [MEIJER DISTRIBUTION INC]4Legacy NDC20241031_1379897d-f4f9-4dac-73d1-9a7d5b6093c3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-064-33412500064333 BOTTLE in 1 CARTON (41250-064-33) > 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (41250-064-52) 3 bottle2014-09-220000-00-00NoNoCurrent