FDA.reportPublic FDA data

Omeprazole

Product NDC
69230-318
11-digit product format
692300318
Labeler code
69230
Product ID
69230-318_ee873df8-2b35-9bc7-e053-2a95a90a0f83
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Camber Consumer Care Inc
Application
ANDA211732
Marketing category
ANDA
Marketing start
2020-03-25
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69230-318-05Omeprazole500 in 1 BOTTLETABLET, DELAYED RELEASE5005
69230-318-10Omeprazole1000 in 1 BOTTLETABLET, DELAYED RELEASE10005
69230-318-32Omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE15
69230-318-32Omeprazole14 in 1 BLISTER PACKTABLET, DELAYED RELEASE145
69230-318-33Omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE25
69230-318-33Omeprazole14 in 1 BLISTER PACKTABLET, DELAYED RELEASE145
69230-318-34Omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE35
69230-318-34Omeprazole14 in 1 BLISTER PACKTABLET, DELAYED RELEASE145
69230-318-35Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE145
69230-318-35Omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE15
69230-318-36Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE145
69230-318-36Omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE25
69230-318-37Omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE35
69230-318-37Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE145

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69230-318-31EA - Each69230-3184a57d6cd-427e-4cad-8365-1e23dd5f380e12021-04-08
69230-318-35EA - Each69230-318006859ef-5ea8-45d9-8819-bf69c254401312021-04-08
69230-318-36EA - Each69230-318f09f87a8-decb-4440-a2f4-1b186aa9a13612021-04-08
69230-318-37EA - Each69230-3187205699e-0a21-476d-af84-77ad10f875be12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69230-318OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [CAMBER CONSUMER CARE INC]5Current NDC, Legacy NDC, 14 package rows20221129_9c856d3a-e38f-4006-a43a-ec1a9fa0f057.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN9c856d3a-e38f-4006-a43a-ec1a9fa0f0575
402014omeprazole 20 MG Delayed Release Oral TabletSCD9c856d3a-e38f-4006-a43a-ec1a9fa0f0575
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY9c856d3a-e38f-4006-a43a-ec1a9fa0f0575
402014omeprazole 20 MG Delayed Release Oral TabletPSNa52842ac-ac9d-4344-9823-b8b2afb079031
402014omeprazole 20 MG Delayed Release Oral TabletSCDa52842ac-ac9d-4344-9823-b8b2afb079031
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSYa52842ac-ac9d-4344-9823-b8b2afb079031

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69230-318-0569230031805500 TABLET, DELAYED RELEASE in 1 BOTTLE (69230-318-05) 2020-10-290000-00-00NoNoCurrent
69230-318-10692300318101000 TABLET, DELAYED RELEASE in 1 BOTTLE (69230-318-10) 2020-10-290000-00-00NoNoCurrent
69230-318-32692300318321 BLISTER PACK in 1 CARTON (69230-318-32) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2020-03-250000-00-00NoNoCurrent
69230-318-33692300318332 BLISTER PACK in 1 CARTON (69230-318-33) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK2 blister pack2020-03-250000-00-00NoNoCurrent
69230-318-34692300318343 BLISTER PACK in 1 CARTON (69230-318-34) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK3 blister pack2020-03-250000-00-00NoNoCurrent
69230-318-35692300318351 BOTTLE in 1 CARTON (69230-318-35) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2020-03-250000-00-00NoNoCurrent
69230-318-36692300318362 BOTTLE in 1 CARTON (69230-318-36) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE2 bottle2020-03-250000-00-00NoNoCurrent
69230-318-37692300318373 BOTTLE in 1 CARTON (69230-318-37) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2020-03-250000-00-00NoNoCurrent