FDA.reportPublic FDA data

Berkley and Jensen Omeprazole

Product NDC
68391-915
11-digit product format
683910915
Labeler code
68391
Product ID
68391-915_74157f10-5953-44de-abf5-b6793f13e70d
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
BJWC
Application
NDA022032
Marketing category
NDA
Marketing start
2008-02-28
Substance
OMEPRAZOLE
Active strength
20 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Berkley and Jensen Omeprazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9
Rxcui402014

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68391-915-55Berkley and Jensen Omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE310
68391-915-55Berkley and Jensen Omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE1410

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9BERKLEY AND JENSEN OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [BJWC]5
OMEPRAZOLEACTIVE MOIETYKG60484QX9BERKLEY AND JENSEN OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [BJWC]5
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZBERKLEY AND JENSEN OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [BJWC]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675BERKLEY AND JENSEN OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [BJWC]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTBERKLEY AND JENSEN OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [BJWC]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOBERKLEY AND JENSEN OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [BJWC]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XBERKLEY AND JENSEN OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [BJWC]5
MONOETHANOLAMINEINACTIVE INGREDIENT5KV86114PTBERKLEY AND JENSEN OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [BJWC]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BERKLEY AND JENSEN OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [BJWC]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JBERKLEY AND JENSEN OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [BJWC]5
SODIUM STEARATEINACTIVE INGREDIENTQU7E2XA9TGBERKLEY AND JENSEN OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [BJWC]5
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIBERKLEY AND JENSEN OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [BJWC]5
TALCINACTIVE INGREDIENT7SEV7J4R1UBERKLEY AND JENSEN OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [BJWC]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBERKLEY AND JENSEN OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [BJWC]5
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMBERKLEY AND JENSEN OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [BJWC]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-915BERKLEY AND JENSEN OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [BJWC]9Current NDC, Legacy NDC, 2 package rows20250213_f74752a8-a686-4c7d-91ad-8c87c4596a7a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSNf74752a8-a686-4c7d-91ad-8c87c4596a7a10
402014omeprazole 20 MG Delayed Release Oral TabletSCDf74752a8-a686-4c7d-91ad-8c87c4596a7a10
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSYf74752a8-a686-4c7d-91ad-8c87c4596a7a10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68391-915-55683910915553 CARTON in 1 CARTON (68391-915-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK3 carton2008-02-280000-00-00NoNoCurrent