FDA.reportPublic FDA data

Omeprazole

Product NDC
51316-061
11-digit product format
513160061
Labeler code
51316
Product ID
51316-061_a3b8b93d-6725-4c5c-8b80-dcc27e408501
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
CVS Pharamacy, Inc
Application
ANDA210593
Marketing category
ANDA
Marketing start
2021-01-09
Substance
OMEPRAZOLE MAGNESIUM
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
OMEPRAZOLE MAGNESIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii426QFE7XLK
Rxcui198051

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
51316-061-28Omeprazole2 in 1 CARTONCAPSULE, DELAYED RELEASE22
51316-061-28Omeprazole28 in 1 BOTTLECAPSULE, DELAYED RELEASE282

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-061OMEPRAZOLE CAPSULE, DELAYED RELEASE [CVS PHARAMACY, INC]2Current NDC, Legacy NDC, 2 package rows20210424_0769e47f-f8f1-4b1c-a8cc-7c8385c74070.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN0769e47f-f8f1-4b1c-a8cc-7c8385c740702
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD0769e47f-f8f1-4b1c-a8cc-7c8385c740702
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY0769e47f-f8f1-4b1c-a8cc-7c8385c740702

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51316-061-28513160061282 BOTTLE in 1 CARTON (51316-061-28) / 28 CAPSULE, DELAYED RELEASE in 1 BOTTLE2 bottle2021-01-090000-00-00NoNoCurrent