FDA.reportPublic FDA data

Omeprazole

Product NDC
68462-396
11-digit product format
684620396
Labeler code
68462
Product ID
68462-396_69b1e229-f845-4608-be48-f97e8d3e2273
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA091672
Marketing category
ANDA
Marketing start
2014-10-31
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, 199119, 200329

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
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
68462-396-01Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE10014
68462-396-10Omeprazole1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100014
68462-396-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3014
68462-396-90Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE9014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-396OMEPRAZOLE CAPSULE, DELAYED RELEASE [GLENMARK PHARMACEUTICALS INC., USA]13Current NDC, Legacy NDC, 4 package rows20230429_c6c22be1-659d-4e71-b292-701e27da201b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSNa19ce586-59b7-4c2e-9e8d-12e8f0f058e216
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDa19ce586-59b7-4c2e-9e8d-12e8f0f058e216
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYa19ce586-59b7-4c2e-9e8d-12e8f0f058e216
199119omeprazole 10 MG Delayed Release Oral CapsulePSNc6c22be1-659d-4e71-b292-701e27da201b14
198051omeprazole 20 MG Delayed Release Oral CapsulePSNc6c22be1-659d-4e71-b292-701e27da201b14
200329omeprazole 40 MG Delayed Release Oral CapsulePSNc6c22be1-659d-4e71-b292-701e27da201b14
199119omeprazole 10 MG Delayed Release Oral CapsuleSCDc6c22be1-659d-4e71-b292-701e27da201b14
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDc6c22be1-659d-4e71-b292-701e27da201b14
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDc6c22be1-659d-4e71-b292-701e27da201b14
199119omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral CapsuleSYc6c22be1-659d-4e71-b292-701e27da201b14
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYc6c22be1-659d-4e71-b292-701e27da201b14
198051omeprazole 20 MG Delayed Release Oral CapsulePSN5bda70ae-c3f6-450b-892f-6814795dd6ca12
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD5bda70ae-c3f6-450b-892f-6814795dd6ca12
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY5bda70ae-c3f6-450b-892f-6814795dd6ca12
198051omeprazole 20 MG Delayed Release Oral CapsulePSNaa8fc2ea-3942-453b-bc19-1e4b14ba692610
198051omeprazole 20 MG Delayed Release Oral CapsulePSNaf85afda-6b0c-d657-e053-2a95a90afb4b10
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDaa8fc2ea-3942-453b-bc19-1e4b14ba692610
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDaf85afda-6b0c-d657-e053-2a95a90afb4b10
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYaf85afda-6b0c-d657-e053-2a95a90afb4b10
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYaa8fc2ea-3942-453b-bc19-1e4b14ba692610
198051omeprazole 20 MG Delayed Release Oral CapsulePSNf43f6cee-7609-4ca0-a409-e4a74575a2778
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDf43f6cee-7609-4ca0-a409-e4a74575a2778
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYf43f6cee-7609-4ca0-a409-e4a74575a2778
198051omeprazole 20 MG Delayed Release Oral CapsulePSN6fa6afcf-33b3-3115-e053-2a91aa0abd0b7
198051omeprazole 20 MG Delayed Release Oral CapsulePSN2d99b4fd-49b3-403d-96a4-0cceda85a95c7
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD6fa6afcf-33b3-3115-e053-2a91aa0abd0b7
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD2d99b4fd-49b3-403d-96a4-0cceda85a95c7
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY2d99b4fd-49b3-403d-96a4-0cceda85a95c7
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY6fa6afcf-33b3-3115-e053-2a91aa0abd0b7
199119omeprazole 10 MG Delayed Release Oral CapsulePSN9c41bcfa-b08b-3ac3-e053-2a95a90ae1c06
198051omeprazole 20 MG Delayed Release Oral CapsulePSN9c41bcfa-b08b-3ac3-e053-2a95a90ae1c06
198051omeprazole 20 MG Delayed Release Oral CapsulePSN17ccdbe0-19c1-498d-8e81-578be549b4e56
200329omeprazole 40 MG Delayed Release Oral CapsulePSN9c41bcfa-b08b-3ac3-e053-2a95a90ae1c06
199119omeprazole 10 MG Delayed Release Oral CapsuleSCD9c41bcfa-b08b-3ac3-e053-2a95a90ae1c06
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD9c41bcfa-b08b-3ac3-e053-2a95a90ae1c06
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD17ccdbe0-19c1-498d-8e81-578be549b4e56
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD9c41bcfa-b08b-3ac3-e053-2a95a90ae1c06
199119omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral CapsuleSY9c41bcfa-b08b-3ac3-e053-2a95a90ae1c06
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY17ccdbe0-19c1-498d-8e81-578be549b4e56
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY9c41bcfa-b08b-3ac3-e053-2a95a90ae1c06
198051omeprazole 20 MG Delayed Release Oral CapsulePSN87e91beb-e8ed-17ac-e053-2995a90a4ba85
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD87e91beb-e8ed-17ac-e053-2995a90a4ba85
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY87e91beb-e8ed-17ac-e053-2995a90a4ba85
198051omeprazole 20 MG Delayed Release Oral CapsulePSN5564c9dc-6f99-6639-e054-00144ff8d46c4
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD5564c9dc-6f99-6639-e054-00144ff8d46c4
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY5564c9dc-6f99-6639-e054-00144ff8d46c4
198051omeprazole 20 MG Delayed Release Oral CapsulePSN6cceb8a3-d35a-f3e0-e053-2991aa0a63603
198051omeprazole 20 MG Delayed Release Oral CapsulePSNdcaadc8c-32d1-476f-b821-973c012b7fa73
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD6cceb8a3-d35a-f3e0-e053-2991aa0a63603
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDdcaadc8c-32d1-476f-b821-973c012b7fa73
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY6cceb8a3-d35a-f3e0-e053-2991aa0a63603
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYdcaadc8c-32d1-476f-b821-973c012b7fa73
198051omeprazole 20 MG Delayed Release Oral CapsulePSN5269d44f-ae9b-3a34-e054-00144ff8d46c2
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD5269d44f-ae9b-3a34-e054-00144ff8d46c2
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY5269d44f-ae9b-3a34-e054-00144ff8d46c2
198051omeprazole 20 MG Delayed Release Oral CapsulePSN3d6e07d1-38b1-f2ab-e063-6294a90a34ac1
198051omeprazole 20 MG Delayed Release Oral CapsulePSN3a9baece-03be-6c77-e063-6394a90a70321
198051omeprazole 20 MG Delayed Release Oral CapsulePSNde384c26-bae0-2adc-e053-2a95a90ad0fd1
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD3d6e07d1-38b1-f2ab-e063-6294a90a34ac1
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDde384c26-bae0-2adc-e053-2a95a90ad0fd1
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD3a9baece-03be-6c77-e063-6394a90a70321
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY3a9baece-03be-6c77-e063-6394a90a70321
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY3d6e07d1-38b1-f2ab-e063-6294a90a34ac1
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYde384c26-bae0-2adc-e053-2a95a90ad0fd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68462-396-0168462039601100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68462-396-01) 2016-10-010000-00-00NoNoCurrent
68462-396-10684620396101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68462-396-10) 2016-10-010000-00-00NoNoCurrent
68462-396-306846203963030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68462-396-30) 2016-10-010000-00-00NoNoCurrent
68462-396-906846203969090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68462-396-90) 2016-10-010000-00-00NoNoCurrent