FDA.reportPublic FDA data

Omeprazole

Product NDC
11673-948
11-digit product format
116730948
Labeler code
11673
Product ID
11673-948_ef059a98-451b-4590-93b4-937b855d6595
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole Magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
UP & UP
Application
ANDA210593
Marketing category
ANDA
Marketing start
2018-07-21
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
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
11673-948-14Omeprazole1 in 1 CARTONCAPSULE, DELAYED RELEASE12
11673-948-14Omeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE142
11673-948-42Omeprazole3 in 1 CARTONCAPSULE, DELAYED RELEASE32
11673-948-42Omeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-948OMEPRAZOLE (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [UP & UP]2Current NDC, Legacy NDC, 4 package rows20201210_ac10cf46-1dcc-483a-83d6-2fcb9896cc19.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSNac10cf46-1dcc-483a-83d6-2fcb9896cc192
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDac10cf46-1dcc-483a-83d6-2fcb9896cc192
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYac10cf46-1dcc-483a-83d6-2fcb9896cc192

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11673-948-14116730948141 BOTTLE in 1 CARTON (11673-948-14) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE1 bottle2018-07-210000-00-00NoNoCurrent
11673-948-42116730948423 BOTTLE in 1 CARTON (11673-948-42) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE3 bottle2018-07-210000-00-00NoNoCurrent