FDA.reportPublic FDA data

Omeprazole

Product NDC
62756-377
11-digit product format
627560377
Labeler code
62756
Product ID
62756-377_676e2f39-d83e-485a-9366-ed14c382e466
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA207891
Marketing category
ANDA
Marketing start
2019-01-01
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
62756-377-11Omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE25
62756-377-11Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE145
62756-377-12Omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE35
62756-377-12Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE145
62756-377-21Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE145
62756-377-21Omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE15
62756-377-70Omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE15
62756-377-70Omeprazole14 in 1 BLISTER PACKTABLET, DELAYED RELEASE145
62756-377-79Omeprazole14 in 1 BLISTER PACKTABLET, DELAYED RELEASE145
62756-377-79Omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE35
62756-377-96Omeprazole14 in 1 BLISTER PACKTABLET, DELAYED RELEASE145
62756-377-96Omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62756-377OMEPRAZOLE TABLET, DELAYED RELEASE [SUN PHARMACEUTICAL INDUSTRIES, INC.]5Current NDC, Legacy NDC, 12 package rows20250507_51c3ef34-b7c1-419e-a784-ae82540c7a22.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN51c3ef34-b7c1-419e-a784-ae82540c7a225
402014omeprazole 20 MG Delayed Release Oral TabletSCD51c3ef34-b7c1-419e-a784-ae82540c7a225
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY51c3ef34-b7c1-419e-a784-ae82540c7a225

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62756-377-11627560377112 BOTTLE in 1 CARTON (62756-377-11) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE2 bottle2019-01-010000-00-00NoNoCurrent
62756-377-12627560377123 BOTTLE in 1 CARTON (62756-377-12) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2019-01-010000-00-00NoNoCurrent
62756-377-21627560377211 BOTTLE in 1 CARTON (62756-377-21) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2019-01-010000-00-00NoNoCurrent
62756-377-70627560377701 BLISTER PACK in 1 CARTON (62756-377-70) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2019-01-010000-00-00NoNoCurrent
62756-377-79627560377793 BLISTER PACK in 1 CARTON (62756-377-79) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK3 blister pack2019-01-010000-00-00NoNoCurrent
62756-377-96627560377962 BLISTER PACK in 1 CARTON (62756-377-96) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK2 blister pack2019-01-010000-00-00NoNoCurrent