FDA.reportPublic FDA data

equaline omeprazole

Product NDC
41163-915
11-digit product format
411630915
Labeler code
41163
Product ID
41163-915_9cf01d8d-1fe8-4350-a23b-065f4d126547
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
NDA022032
Marketing category
NDA
Marketing start
2008-02-22
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
equaline omeprazole
Listing expiration
2026-12-31

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
41163-915-01equaline omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE148
41163-915-01equaline omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE18
41163-915-30equaline omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE28
41163-915-30equaline omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE148
41163-915-55equaline omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE38
41163-915-55equaline omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE148
41163-915-74equaline omeprazole1 in 1 BLISTER PACKTABLET, DELAYED RELEASE18
41163-915-74equaline omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE148

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
41163-915-01EA - Each41163-915da93dc38-7607-42a9-84f5-6cd8d83b3e1812016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9EQUALINE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SUPERVALU INC]4
OMEPRAZOLEACTIVE MOIETYKG60484QX9EQUALINE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SUPERVALU INC]4
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZEQUALINE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SUPERVALU INC]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675EQUALINE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SUPERVALU INC]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTEQUALINE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SUPERVALU INC]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEQUALINE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SUPERVALU INC]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XEQUALINE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SUPERVALU INC]4
MONOETHANOLAMINEINACTIVE INGREDIENT5KV86114PTEQUALINE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SUPERVALU INC]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3EQUALINE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SUPERVALU INC]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JEQUALINE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SUPERVALU INC]4
SODIUM STEARATEINACTIVE INGREDIENTQU7E2XA9TGEQUALINE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SUPERVALU INC]4
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIEQUALINE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SUPERVALU INC]4
TALCINACTIVE INGREDIENT7SEV7J4R1UEQUALINE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SUPERVALU INC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEQUALINE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SUPERVALU INC]4
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMEQUALINE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [SUPERVALU INC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-915EQUALINE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [UNITED NATURAL FOODS, INC. DBA UNFI]8Current NDC, Legacy NDC, 8 package rows20230804_b6c87a6a-253a-4455-9b7d-62f506da592e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSNb6c87a6a-253a-4455-9b7d-62f506da592e8
402014omeprazole 20 MG Delayed Release Oral TabletSCDb6c87a6a-253a-4455-9b7d-62f506da592e8
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSYb6c87a6a-253a-4455-9b7d-62f506da592e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-915-01411630915011 BOTTLE in 1 CARTON (41163-915-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2011-09-270000-00-00NoNoCurrent
41163-915-30411630915302 CARTON in 1 CARTON (41163-915-30) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK2 carton2008-02-220000-00-00NoNoCurrent
41163-915-55411630915553 CARTON in 1 CARTON (41163-915-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK3 carton2008-02-250000-00-00NoNoCurrent
41163-915-744116309157414 BLISTER PACK in 1 CARTON (41163-915-74) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK14 blister pack2008-02-220000-00-00NoNoCurrent