FDA.reportPublic FDA data

Omeprazole

Product NDC
51660-029
11-digit product format
516600029
Labeler code
51660
Product ID
51660-029_e9ea61cb-d280-42b0-8819-34117270c618
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
OHM LABORATORIES INC.
Application
ANDA207891
Marketing category
ANDA
Marketing start
2019-06-01
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
51660-029-14Omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE18
51660-029-14Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE148
51660-029-27Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE148
51660-029-27Omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE28
51660-029-44Omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE38
51660-029-44Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE148

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51660-029-14EA - Each51660-02945ebfd55-6028-482d-9ea7-b6f7aee8b63612019-10-07
51660-029-27EA - Each51660-02972b7f844-f42f-4648-8fdf-47ca24147a8412020-09-14
51660-029-44EA - Each51660-02908c60da7-385a-4af7-a32d-e582c95ce02012019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51660-029OMEPRAZOLE TABLET, DELAYED RELEASE [OHM LABORATORIES INC.]8Current NDC, Legacy NDC, 6 package rows20240302_35a95bec-51b9-465b-aa93-ad26afb87be8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN35a95bec-51b9-465b-aa93-ad26afb87be88
402014omeprazole 20 MG Delayed Release Oral TabletSCD35a95bec-51b9-465b-aa93-ad26afb87be88
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY35a95bec-51b9-465b-aa93-ad26afb87be88
402014omeprazole 20 MG Delayed Release Oral TabletPSN44f59d88-d401-950b-e063-6294a90a2a501
402014omeprazole 20 MG Delayed Release Oral TabletSCD44f59d88-d401-950b-e063-6294a90a2a501
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY44f59d88-d401-950b-e063-6294a90a2a501

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51660-029-14516600029141 BOTTLE in 1 CARTON (51660-029-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2019-06-010000-00-00NoNoCurrent
51660-029-27516600029272 BOTTLE in 1 CARTON (51660-029-27) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE2 bottle2019-06-010000-00-00NoNoCurrent
51660-029-44516600029443 BOTTLE in 1 CARTON (51660-029-44) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2019-06-010000-00-00NoNoCurrent