FDA.reportPublic FDA data

Omeprazole

Product NDC
60687-608
11-digit product format
606870608
Labeler code
60687
Product ID
60687-608_459ef81b-22fe-40fe-e063-6294a90af7ad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA078490
Marketing category
ANDA
Marketing start
2021-08-04
Substance
OMEPRAZOLE
Active strength
40 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
OMEPRAZOLE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9
Rxcui198051, 200329

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
60687-608-01Omeprazole100 in 1 CARTONCAPSULE, DELAYED RELEASE1005
60687-608-11Omeprazole1 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-608OMEPRAZOLE CAPSULE, DELAYED RELEASE [AMERICAN HEALTH PACKAGING]3Current NDC, Legacy NDC, 2 package rows20240202_205652e1-7fbc-4b6a-bbd6-2fd346d812df.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN205652e1-7fbc-4b6a-bbd6-2fd346d812df5
200329omeprazole 40 MG Delayed Release Oral CapsulePSN205652e1-7fbc-4b6a-bbd6-2fd346d812df5
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD205652e1-7fbc-4b6a-bbd6-2fd346d812df5
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD205652e1-7fbc-4b6a-bbd6-2fd346d812df5
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY205652e1-7fbc-4b6a-bbd6-2fd346d812df5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-608-0160687060801100 BLISTER PACK in 1 CARTON (60687-608-01) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (60687-608-11) 100 blister pack2021-08-040000-00-00NoNoCurrent
60687-608-11606870608111 in 1 BLISTER PACKHistorical