exchange select omeprazole

Product NDC
55301-915
11-digit product format
553010915
Labeler code
55301
Product ID
55301-915_8adc4bc1-677f-4ad1-b301-bb5f25ce0205
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Army & Air Force Exchange Service
Application
NDA022032
Marketing category
NDA
Marketing start
2008-10-28
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
exchange select 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
55301-915-55exchange select omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE36
55301-915-55exchange select omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE146
55301-915-74exchange select omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE146
55301-915-74exchange select omeprazole1 in 1 BLISTER PACKTABLET, DELAYED RELEASE16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9EXCHANGE SELECT OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [ARMY & AIR FORCE EXCHANGE SERVICE]3
OMEPRAZOLEACTIVE MOIETYKG60484QX9EXCHANGE SELECT OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [ARMY & AIR FORCE EXCHANGE SERVICE]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZEXCHANGE SELECT OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [ARMY & AIR FORCE EXCHANGE SERVICE]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675EXCHANGE SELECT OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [ARMY & AIR FORCE EXCHANGE SERVICE]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTEXCHANGE SELECT OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [ARMY & AIR FORCE EXCHANGE SERVICE]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOEXCHANGE SELECT OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [ARMY & AIR FORCE EXCHANGE SERVICE]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XEXCHANGE SELECT OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [ARMY & AIR FORCE EXCHANGE SERVICE]3
MONOETHANOLAMINEINACTIVE INGREDIENT5KV86114PTEXCHANGE SELECT OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [ARMY & AIR FORCE EXCHANGE SERVICE]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3EXCHANGE SELECT OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [ARMY & AIR FORCE EXCHANGE SERVICE]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JEXCHANGE SELECT OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [ARMY & AIR FORCE EXCHANGE SERVICE]3
SODIUM STEARATEINACTIVE INGREDIENTQU7E2XA9TGEXCHANGE SELECT OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [ARMY & AIR FORCE EXCHANGE SERVICE]3
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIEXCHANGE SELECT OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [ARMY & AIR FORCE EXCHANGE SERVICE]3
TALCINACTIVE INGREDIENT7SEV7J4R1UEXCHANGE SELECT OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [ARMY & AIR FORCE EXCHANGE SERVICE]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPEXCHANGE SELECT OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [ARMY & AIR FORCE EXCHANGE SERVICE]3
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMEXCHANGE SELECT OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [ARMY & AIR FORCE EXCHANGE SERVICE]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55301-915EXCHANGE SELECT OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [ARMY & AIR FORCE EXCHANGE SERVICE]6Current NDC, Legacy NDC, 4 package rows20241225_22b4492d-7afe-410f-97bf-57e4a57b1c27.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN22b4492d-7afe-410f-97bf-57e4a57b1c276
402014omeprazole 20 MG Delayed Release Oral TabletSCD22b4492d-7afe-410f-97bf-57e4a57b1c276
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY22b4492d-7afe-410f-97bf-57e4a57b1c276

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55301-915-55553010915553 CARTON in 1 CARTON (55301-915-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK3 carton2008-10-280000-00-00NoNoCurrent
55301-915-745530109157414 BLISTER PACK in 1 CARTON (55301-915-74) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK14 blister pack2008-11-180000-00-00NoNoCurrent