Omeprazole

Product NDC
55154-2332
11-digit product format
551542332
Labeler code
55154
Product ID
55154-2332_b791235a-9992-434e-9b31-bbd5ed4e1c81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA091352
Marketing category
ANDA
Marketing start
2012-11-23
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
Rxcui198051

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
55154-2332-0Omeprazole10 in 1 BAGCAPSULE, DELAYED RELEASE108
55154-2332-0Omeprazole1 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-2332OMEPRAZOLE CAPSULE, DELAYED RELEASE [CARDINAL HEALTH 107, LLC]7Current NDC, Legacy NDC, 2 package rows20250116_fbd71fd8-3f36-46a1-bc76-53f6820d42a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSNfbd71fd8-3f36-46a1-bc76-53f6820d42a28
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDfbd71fd8-3f36-46a1-bc76-53f6820d42a28
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYfbd71fd8-3f36-46a1-bc76-53f6820d42a28

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-2332-05515423320010 BLISTER PACK in 1 BAG (55154-2332-0) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK10 blister pack2012-11-230000-00-00NoNoCurrent