FDA.reportPublic FDA data

Omeprazole

Product NDC
71335-1395
11-digit product format
713351395
Labeler code
71335
Product ID
71335-1395_f5868802-1b1f-4d48-8793-39d25a65b0d8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076048
Marketing category
ANDA
Marketing start
2009-01-21
Marketing end
2027-01-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Omeprazole

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1395-1Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE605
71335-1395-2Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE305
71335-1395-3Omeprazole20 in 1 BOTTLECAPSULE, DELAYED RELEASE205
71335-1395-4Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE905
71335-1395-5Omeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE145
71335-1395-6Omeprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE1205
71335-1395-7Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE1005
71335-1395-8Omeprazole180 in 1 BOTTLECAPSULE, DELAYED RELEASE1805

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1395OMEPRAZOLE CAPSULE, DELAYED RELEASE [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 8 package rows20241004_44349466-73ea-4053-8ff6-5b4b7372c9cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN44349466-73ea-4053-8ff6-5b4b7372c9cd5
200329omeprazole 40 MG Delayed Release Oral CapsulePSN44349466-73ea-4053-8ff6-5b4b7372c9cd5
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD44349466-73ea-4053-8ff6-5b4b7372c9cd5
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD44349466-73ea-4053-8ff6-5b4b7372c9cd5
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY44349466-73ea-4053-8ff6-5b4b7372c9cd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1395-17133513950160 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1395-1) 2012-02-012027-01-31NoNoCurrent
71335-1395-27133513950230 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1395-2) 2012-02-012027-01-31NoNoCurrent
71335-1395-37133513950320 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1395-3) 2012-02-012027-01-31NoNoCurrent
71335-1395-47133513950490 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1395-4) 2012-02-012027-01-31NoNoCurrent
71335-1395-57133513950514 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1395-5) 2012-02-012027-01-31NoNoCurrent
71335-1395-671335139506120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1395-6) 2012-02-012027-01-31NoNoCurrent
71335-1395-771335139507100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1395-7) 2012-02-012027-01-31NoNoCurrent
71335-1395-871335139508180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71335-1395-8) 2012-02-012027-01-31NoNoCurrent