FDA.reportPublic FDA data

Omeprazole

Product NDC
63941-997
11-digit product format
639410997
Labeler code
63941
Product ID
63941-997_9c033207-ae1c-4212-aeef-3bb5bfef6fca
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
VALU MERCHANDISERS COMPANY
Application
ANDA207891
Marketing category
ANDA
Marketing start
2018-07-20
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
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
63941-997-14Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE142
63941-997-14Omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE12
63941-997-42Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE142
63941-997-42Omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-997OMEPRAZOLE TABLET, DELAYED RELEASE [VALU MERCHANDISERS COMPANY]2Current NDC, 4 package rows20231215_7b2d41b6-3e36-4973-b5f6-adf9b828f40d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN7b2d41b6-3e36-4973-b5f6-adf9b828f40d2
402014omeprazole 20 MG Delayed Release Oral TabletSCD7b2d41b6-3e36-4973-b5f6-adf9b828f40d2
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY7b2d41b6-3e36-4973-b5f6-adf9b828f40d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63941-997-14639410997141 BOTTLE in 1 CARTON (63941-997-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2018-07-21NoNoHistorical
63941-997-42639410997423 BOTTLE in 1 CARTON (63941-997-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2018-07-21NoNoHistorical