Omeprazole

Product NDC
41250-349
11-digit product format
412500349
Labeler code
41250
Product ID
41250-349_e3d7b200-cb51-46f2-aebf-b95ddac1b664
Type
HUMAN OTC DRUG
Nonproprietary name
omeprazole
Dosage form
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route
ORAL
Labeler
Meijer Distribution Inc
Application
NDA209400
Marketing category
NDA
Marketing start
2018-03-13
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
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
41250-349-55Omeprazole14 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D144
41250-349-55Omeprazole3 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D34
41250-349-74Omeprazole1 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D14
41250-349-74Omeprazole14 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D144

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-349OMEPRAZOLE TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [MEIJER DISTRIBUTION INC]4Current NDC, Legacy NDC, 4 package rows20240713_d54e1097-bd56-4371-8e59-8ceab1a5e824.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2003656omeprazole 20 MG Delayed Release Disintegrating Oral TabletPSNd54e1097-bd56-4371-8e59-8ceab1a5e8244
2003656omeprazole 20 MG Disintegrating Oral TabletSCDd54e1097-bd56-4371-8e59-8ceab1a5e8244
2003656omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Disintegrating Oral TabletSYd54e1097-bd56-4371-8e59-8ceab1a5e8244

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-349-55412500349553 CARTON in 1 CARTON (41250-349-55) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK3 carton2018-03-130000-00-00NoNoCurrent
41250-349-74412500349741 CARTON in 1 CARTON (41250-349-74) > 14 BLISTER PACK in 1 CARTON > 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK1 carton2018-03-130000-00-00NoNoCurrent