FDA.reportPublic FDA data

Omeprazole

Product NDC
72036-981
11-digit product format
720360981
Labeler code
72036
Product ID
72036-981_ca9797c6-5708-4d45-bd1a-c670077e1a0b
Type
HUMAN OTC DRUG
Nonproprietary name
OMEPRAZOLE
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
HARRIS TEETER
Application
ANDA207891
Marketing category
ANDA
Marketing start
2020-09-16
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
72036-981-14Omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE13
72036-981-14Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE143
72036-981-42Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE143
72036-981-42Omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72036-981OMEPRAZOLE TABLET, DELAYED RELEASE [HARRIS TEETER]3Current NDC, Legacy NDC, 4 package rows20221229_c618964f-4b16-448e-851b-e6b2a816c660.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSNc618964f-4b16-448e-851b-e6b2a816c6603
402014omeprazole 20 MG Delayed Release Oral TabletSCDc618964f-4b16-448e-851b-e6b2a816c6603
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSYc618964f-4b16-448e-851b-e6b2a816c6603

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72036-981-14720360981141 BOTTLE in 1 CARTON (72036-981-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2020-09-160000-00-00NoNoCurrent
72036-981-42720360981423 BOTTLE in 1 CARTON (72036-981-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2020-09-160000-00-00NoNoCurrent