FDA.reportPublic FDA data

Omeprazole

Product NDC
60760-747
11-digit product format
607600747
Labeler code
60760
Product ID
60760-747_508c7a25-e8cc-b3d3-e063-6294a90ab3de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA078490
Marketing category
ANDA
Marketing start
2014-03-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Omeprazole
Listing expiration
2027-12-31

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
60760-747-07Omeprazole7 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE73
60760-747-30Omeprazole30 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE303
60760-747-60Omeprazole60 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE603
60760-747-90Omeprazole90 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE903

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN4c0cf466-f9e8-390e-e063-6294a90a2ed83
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD4c0cf466-f9e8-390e-e063-6294a90a2ed83
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY4c0cf466-f9e8-390e-e063-6294a90a2ed83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60760-747-07607600747077 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-747-07) 2026-04-23NoNoCurrent
60760-747-306076007473030 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-747-30) 2026-03-30NoNoCurrent
60760-747-606076007476060 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-747-60) 2026-03-30NoNoCurrent
60760-747-906076007479090 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-747-90) 2026-03-02NoNoCurrent