FDA.reportPublic FDA data

Good Sense Omeprazole

Product NDC
0113-0915
11-digit product format
001130915
Labeler code
0113
Product ID
0113-0915_1d135e1c-1e90-4e42-a2c7-2ef3b3fc6545
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
L. Perrigo Company
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Good Sense 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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
0113-0915-01Good Sense Omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE18
0113-0915-01Good Sense Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE148
0113-0915-03Good Sense Omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE38
0113-0915-03Good Sense Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE148
0113-0915-30Good Sense Omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE28
0113-0915-30Good Sense Omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE148
0113-0915-55Good Sense Omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE38
0113-0915-55Good Sense Omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE148
0113-0915-74Good Sense Omeprazole1 in 1 BLISTER PACKTABLET, DELAYED RELEASE18
0113-0915-74Good Sense Omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE148

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0915-03EA - Each0113-091572580d7e-1510-41c1-b4b6-5ee09236ccba12023-01-09
0113-0915-30EA - Each0113-091509a1efbb-e64e-4eb2-9e47-59808d97656112012-07-24
0113-0915-55EA - Each0113-0915d08fc726-1e50-46e1-8710-2395227346c112012-07-24
0113-0915-74EA - Each0113-0915b41d3dfd-1637-4e84-a9fc-5f81a3cb8dd212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9GOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [L. PERRIGO COMPANY]4
OMEPRAZOLEACTIVE MOIETYKG60484QX9GOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [L. PERRIGO COMPANY]4
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZGOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [L. PERRIGO COMPANY]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675GOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [L. PERRIGO COMPANY]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTGOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [L. PERRIGO COMPANY]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [L. PERRIGO COMPANY]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [L. PERRIGO COMPANY]4
MONOETHANOLAMINEINACTIVE INGREDIENT5KV86114PTGOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [L. PERRIGO COMPANY]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3GOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [L. PERRIGO COMPANY]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [L. PERRIGO COMPANY]4
SODIUM STEARATEINACTIVE INGREDIENTQU7E2XA9TGGOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [L. PERRIGO COMPANY]4
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIGOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [L. PERRIGO COMPANY]4
TALCINACTIVE INGREDIENT7SEV7J4R1UGOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [L. PERRIGO COMPANY]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [L. PERRIGO COMPANY]4
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMGOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [L. PERRIGO COMPANY]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0915GOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [L. PERRIGO COMPANY]8Current NDC, Legacy NDC, 10 package rows20241225_11dfbf6c-59bf-4a30-b627-f49ccd31c0d0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN11dfbf6c-59bf-4a30-b627-f49ccd31c0d08
402014omeprazole 20 MG Delayed Release Oral TabletSCD11dfbf6c-59bf-4a30-b627-f49ccd31c0d08
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY11dfbf6c-59bf-4a30-b627-f49ccd31c0d08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0915-01001130915011 BOTTLE in 1 CARTON (0113-0915-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2008-02-28NoNoCurrent
0113-0915-03001130915033 BOTTLE in 1 CARTON (0113-0915-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2017-06-080000-00-00NoNoCurrent
0113-0915-30001130915302 CARTON in 1 CARTON (0113-0915-30) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK2 carton2008-02-280000-00-00NoNoCurrent
0113-0915-55001130915553 CARTON in 1 CARTON (0113-0915-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK3 carton2008-02-280000-00-00NoNoCurrent
0113-0915-740011309157414 BLISTER PACK in 1 CARTON (0113-0915-74) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK14 blister pack2008-02-280000-00-00NoNoCurrent