FDA.reportPublic FDA data

Omeprazole

Product NDC
68462-395
11-digit product format
684620395
Labeler code
68462
Product ID
68462-395_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
10 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
OMEPRAZOLE10 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
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
68462-395-01Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE10014
68462-395-10Omeprazole1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100014
68462-395-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3014
68462-395-90Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-395-01EA - Each68462-39570bc6efd-bd8d-4912-9800-08e3146581a512016-10-06
68462-395-10EA - Each68462-39549f0f9c7-e8c8-41c2-a57e-3f9937d4ba6312016-10-06
68462-395-30EA - Each68462-395cc07caa7-5796-4004-8458-4feeaa86979812016-10-06
68462-395-90EA - Each68462-39521b8cc04-68bc-4b7b-9795-b915bcb21c7b12016-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-395OMEPRAZOLE 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
199119omeprazole 10 MG Delayed Release Oral CapsulePSNf1e47c7a-73a0-49a5-9e17-f863af7b07a1102
199119omeprazole 10 MG Delayed Release Oral CapsuleSCDf1e47c7a-73a0-49a5-9e17-f863af7b07a1102
199119omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral CapsuleSYf1e47c7a-73a0-49a5-9e17-f863af7b07a1102
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
199119omeprazole 10 MG Delayed Release Oral CapsulePSN9c41bcfa-b08b-3ac3-e053-2a95a90ae1c06
198051omeprazole 20 MG Delayed Release Oral CapsulePSN9c41bcfa-b08b-3ac3-e053-2a95a90ae1c06
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
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 CapsuleSY9c41bcfa-b08b-3ac3-e053-2a95a90ae1c06
199119omeprazole 10 MG Delayed Release Oral CapsulePSNa53ea447-add5-4ed5-aa7e-975b13d90e753
199119omeprazole 10 MG Delayed Release Oral CapsuleSCDa53ea447-add5-4ed5-aa7e-975b13d90e753
199119omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral CapsuleSYa53ea447-add5-4ed5-aa7e-975b13d90e753

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68462-395-0168462039501100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68462-395-01) 2016-10-010000-00-00NoNoCurrent
68462-395-10684620395101000 in 1 BOTTLEHistorical
68462-395-306846203953030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68462-395-30) 2016-10-010000-00-00NoNoCurrent
68462-395-906846203959090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68462-395-90) 2016-10-010000-00-00NoNoCurrent