FDA.reportPublic FDA data

good sense omeprazole

Product NDC
0113-0520
11-digit product format
001130520
Labeler code
0113
Product ID
0113-0520_5e2cb7f9-93ec-4919-9648-0ecb1c5fe086
Type
HUMAN OTC DRUG
Nonproprietary name
omeprazole
Dosage form
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route
ORAL
Labeler
L. Perrigo Company
Application
NDA209400
Marketing category
NDA
Marketing start
2018-06-19
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
Rxcui2003656

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-0520-55good sense omeprazole3 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D34
0113-0520-55good sense omeprazole14 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D144
0113-0520-74good sense omeprazole14 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D144
0113-0520-74good sense omeprazole1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING, D14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0113-0520-55EA - Each0113-052020b899fd-54b6-46d3-9c45-22c3788ede8812020-04-20
0113-0520-74EA - Each0113-05205ebcbc9b-cb87-4d63-9b02-b454c6d569d612020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-0520GOOD SENSE OMEPRAZOLE (OMEPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [L. PERRIGO COMPANY]4Current NDC, Legacy NDC, 4 package rows20250130_dcd93796-8904-415d-a379-c4ea590cf544.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2003656omeprazole 20 MG Delayed Release Disintegrating Oral TabletPSNdcd93796-8904-415d-a379-c4ea590cf5444
2003656omeprazole 20 MG Disintegrating Oral TabletSCDdcd93796-8904-415d-a379-c4ea590cf5444
2003656omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Disintegrating Oral TabletSYdcd93796-8904-415d-a379-c4ea590cf5444

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0113-0520-55001130520553 CARTON in 1 CARTON (0113-0520-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK3 carton2018-06-210000-00-00NoNoCurrent
0113-0520-740011305207414 BLISTER PACK in 1 CARTON (0113-0520-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK14 blister pack2018-06-190000-00-00NoNoCurrent