FDA.reportPublic FDA data

Omeprazole

Product NDC
68462-397
11-digit product format
684620397
Labeler code
68462
Product ID
68462-397_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
40 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
OMEPRAZOLE40 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
68462-397-01Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE10014
68462-397-10Omeprazole1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100014
68462-397-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3014
68462-397-90Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-397-01EA - Each68462-3970e23cb68-c0fe-4923-8e4d-0157b1e3660512016-10-06
68462-397-10EA - Each68462-3976e3028ee-51ad-4338-b796-e371e88e60eb12016-10-06
68462-397-30EA - Each68462-3971795df57-f120-4dfe-aeb5-51501449122512016-10-06
68462-397-90EA - Each68462-397a16948ec-4813-4062-92ed-5814bcef15fa12016-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
OMEPRAZOLEACTIVE MOIETYKG60484QX9OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
GELATININACTIVE INGREDIENT2G86QN327LOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
MAGNESIUM HYDROXIDEINACTIVE INGREDIENTNBZ3QY004SOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
MANNITOLINACTIVE INGREDIENT3OWL53L36AOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
POVIDONE K30INACTIVE INGREDIENTU725QWY32XOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
SHELLACINACTIVE INGREDIENT46N107B71OOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE DR CAPSULE, DELAYED RELEASE [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-397OMEPRAZOLE 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
200329omeprazole 40 MG Delayed Release Oral CapsulePSNd9b3918c-a66e-4277-8b8f-b7ece93fa7db21
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDd9b3918c-a66e-4277-8b8f-b7ece93fa7db21
200329omeprazole 40 MG Delayed Release Oral CapsulePSN2b7491dd-19f5-42e0-b901-7ba71a3820c720
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD2b7491dd-19f5-42e0-b901-7ba71a3820c720
200329omeprazole 40 MG Delayed Release Oral CapsulePSNd1e0c8fc-1f15-45a4-a80f-653a1dae5e5616
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDd1e0c8fc-1f15-45a4-a80f-653a1dae5e5616
200329omeprazole 40 MG Delayed Release Oral CapsulePSN30e58465-c5d2-4925-85bb-53faa6135c5c15
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD30e58465-c5d2-4925-85bb-53faa6135c5c15
199119omeprazole 10 MG Delayed Release Oral CapsulePSNc6c22be1-659d-4e71-b292-701e27da201b14
198051omeprazole 20 MG Delayed Release Oral CapsulePSNc6c22be1-659d-4e71-b292-701e27da201b14
198051omeprazole 20 MG Delayed Release Oral CapsulePSNc6bc8fb7-2862-464a-b7c9-e409034f072a14
200329omeprazole 40 MG Delayed Release Oral CapsulePSNc6c22be1-659d-4e71-b292-701e27da201b14
200329omeprazole 40 MG Delayed Release Oral CapsulePSNc6bc8fb7-2862-464a-b7c9-e409034f072a14
199119omeprazole 10 MG Delayed Release Oral CapsuleSCDc6c22be1-659d-4e71-b292-701e27da201b14
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDc6bc8fb7-2862-464a-b7c9-e409034f072a14
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDc6c22be1-659d-4e71-b292-701e27da201b14
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDc6c22be1-659d-4e71-b292-701e27da201b14
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDc6bc8fb7-2862-464a-b7c9-e409034f072a14
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 (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYc6bc8fb7-2862-464a-b7c9-e409034f072a14
200329omeprazole 40 MG Delayed Release Oral CapsulePSNfa0395a7-4353-4d64-9de8-d15857a7031c8
200329omeprazole 40 MG Delayed Release Oral CapsulePSNc8bf92c9-1bab-7985-e053-2995a90a02258
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDc8bf92c9-1bab-7985-e053-2995a90a02258
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDfa0395a7-4353-4d64-9de8-d15857a7031c8
200329omeprazole 40 MG Delayed Release Oral CapsulePSN5ad413ed-a21b-4f8b-9322-8fbb813b14d37
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD5ad413ed-a21b-4f8b-9322-8fbb813b14d37
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
200329omeprazole 40 MG Delayed Release Oral CapsulePSN4be616c4-1b9a-5654-e054-00144ff88e886
200329omeprazole 40 MG Delayed Release Oral CapsulePSN1eb34cff-59c5-4411-b587-10207ffb58c46
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 CapsuleSCD1eb34cff-59c5-4411-b587-10207ffb58c46
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD9c41bcfa-b08b-3ac3-e053-2a95a90ae1c06
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD4be616c4-1b9a-5654-e054-00144ff88e886
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
200329omeprazole 40 MG Delayed Release Oral CapsulePSN80ef3211-8502-4e06-944f-6e406a9edfa03
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD80ef3211-8502-4e06-944f-6e406a9edfa03
200329omeprazole 40 MG Delayed Release Oral CapsulePSNbab55f83-ba03-49a0-842a-19c9976b7fe82
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDbab55f83-ba03-49a0-842a-19c9976b7fe82
200329omeprazole 40 MG Delayed Release Oral CapsulePSN9af00688-8cd1-35c5-e053-2995a90ab0111
200329omeprazole 40 MG Delayed Release Oral CapsulePSN26b9016c-d651-688b-e063-6394a90a8fb21
200329omeprazole 40 MG Delayed Release Oral CapsulePSN4f5c91e6-6377-ca94-e063-6294a90a2f991
200329omeprazole 40 MG Delayed Release Oral CapsulePSN1e1a997a-9207-441c-e063-6294a90a503e1
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD4f5c91e6-6377-ca94-e063-6294a90a2f991
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD26b9016c-d651-688b-e063-6394a90a8fb21
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD9af00688-8cd1-35c5-e053-2995a90ab0111
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD1e1a997a-9207-441c-e063-6294a90a503e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68462-397-0168462039701100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68462-397-01) 2016-10-010000-00-00NoNoCurrent
68462-397-10684620397101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68462-397-10) 2016-10-010000-00-00NoNoCurrent
68462-397-306846203973030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68462-397-30) 2016-10-010000-00-00NoNoCurrent
68462-397-906846203979090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68462-397-90) 2016-10-010000-00-00NoNoCurrent