FDA.reportPublic FDA data

Omeprazole

Product NDC
60505-0145
11-digit product format
605050145
Labeler code
60505
Product ID
60505-0145_8619e520-d106-4778-e92a-09b919b55c70
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Apotex Corp
Application
ANDA076048
Marketing category
ANDA
Marketing start
2003-11-11
Marketing end
2027-01-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Omeprazole

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
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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
60505-0145-0Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3035
60505-0145-1Omeprazole1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100035
60505-0145-2Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE10035
60505-0145-3Omeprazole7 in 1 CARTONCAPSULE, DELAYED RELEASE735
60505-0145-3Omeprazole10 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE1035
60505-0145-7Omeprazole10 in 1 CARTONCAPSULE, DELAYED RELEASE1035
60505-0145-7Omeprazole10 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE1035

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0145-0EA - Each60505-014575ce3b5d-8269-41ec-9c0f-023d1757c95612012-07-24
60505-0145-1EA - Each60505-01459d84a9fb-3618-4057-98fe-763f7bfa48b312012-07-24
60505-0145-2EA - Each60505-014531a33844-de11-4a38-aef8-e675081b407512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OmeprazoleACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
OmeprazoleACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
ALCOHOLINACTIVE INGREDIENT3K9958V90MOMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
AMMONIAINACTIVE INGREDIENT5138Q19F1XOMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
GELATININACTIVE INGREDIENT2G86QN327LOMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
MAGNESIUM HYDROXIDEINACTIVE INGREDIENTNBZ3QY004SOMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
MANNITOLINACTIVE INGREDIENT3OWL53L36AOMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JOMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TOMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
POVIDONE K30INACTIVE INGREDIENTU725QWY32XOMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
SHELLACINACTIVE INGREDIENT46N107B71OOMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]15
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
OmeprazoleACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MOMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
AMMONIAINACTIVE INGREDIENT5138Q19F1XOMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
GELATININACTIVE INGREDIENT2G86QN327LOMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
MAGNESIUM HYDROXIDEINACTIVE INGREDIENTNBZ3QY004SOMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
MANNITOLINACTIVE INGREDIENT3OWL53L36AOMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JOMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TOMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
POVIDONE K30INACTIVE INGREDIENTU725QWY32XOMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
SHELLACINACTIVE INGREDIENT46N107B71OOMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0145OMEPRAZOLE CAPSULE, DELAYED RELEASE [APOTEX CORP]35Current NDC, Legacy NDC, 7 package rows20240423_b83329ac-a65e-b3af-a3fb-c5a6c740e5e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199119omeprazole 10 MG Delayed Release Oral CapsulePSNb83329ac-a65e-b3af-a3fb-c5a6c740e5e735
198051omeprazole 20 MG Delayed Release Oral CapsulePSNb83329ac-a65e-b3af-a3fb-c5a6c740e5e735
200329omeprazole 40 MG Delayed Release Oral CapsulePSNb83329ac-a65e-b3af-a3fb-c5a6c740e5e735
199119omeprazole 10 MG Delayed Release Oral CapsuleSCDb83329ac-a65e-b3af-a3fb-c5a6c740e5e735
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDb83329ac-a65e-b3af-a3fb-c5a6c740e5e735
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDb83329ac-a65e-b3af-a3fb-c5a6c740e5e735
199119omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral CapsuleSYb83329ac-a65e-b3af-a3fb-c5a6c740e5e735
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYb83329ac-a65e-b3af-a3fb-c5a6c740e5e735
199119omeprazole 10 MG Delayed Release Oral CapsulePSN03ac077f-3873-4087-96d0-89049161dea97
198051omeprazole 20 MG Delayed Release Oral CapsulePSN03ac077f-3873-4087-96d0-89049161dea97
199119omeprazole 10 MG Delayed Release Oral CapsuleSCD03ac077f-3873-4087-96d0-89049161dea97
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD03ac077f-3873-4087-96d0-89049161dea97
199119omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral CapsuleSY03ac077f-3873-4087-96d0-89049161dea97
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY03ac077f-3873-4087-96d0-89049161dea97

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-0145-06050501450030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0145-0) 2003-11-110000-00-00NoNoCurrent
60505-0145-1605050145011000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0145-1) 2003-11-110000-00-00NoNoCurrent
60505-0145-260505014502100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (60505-0145-2) 2003-11-112027-01-31NoNoCurrent
60505-0145-3605050145037 BLISTER PACK in 1 CARTON (60505-0145-3) > 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK7 blister pack2003-11-110000-00-00NoNoCurrent
60505-0145-76050501450710 BLISTER PACK in 1 CARTON (60505-0145-7) > 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK10 blister pack2003-11-110000-00-00NoNoCurrent