FDA.reportPublic FDA data

Omeprazole

Product NDC
52959-722
11-digit product format
529590722
Labeler code
52959
Product ID
52959-722_beac7b55-14cd-45b4-8024-bd117222e6cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA075876
Marketing category
ANDA
Marketing start
2011-01-14
Marketing end
0000-00-00
Substance
OMEPRAZOLE
Active strength
20 mg/1
Pharmacologic classes
Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52959-722-152020-01-31C16284748780-19d75b9d0-b137-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use omeprazole delayed-release capsules safely and effectively. See full prescribing information for omeprazole delayed-release capsules. Omeprazole Delayed-Release Capsules, USP Initial U.S. Approval: 1989
52959-722-202020-01-31C16284748780-19d75b9d0-b137-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use omeprazole delayed-release capsules safely and effectively. See full prescribing information for omeprazole delayed-release capsules. Omeprazole Delayed-Release Capsules, USP Initial U.S. Approval: 1989
52959-722-302020-01-31C16284748780-19d75b9d0-b137-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use omeprazole delayed-release capsules safely and effectively. See full prescribing information for omeprazole delayed-release capsules. Omeprazole Delayed-Release Capsules, USP Initial U.S. Approval: 1989
52959-722-602020-01-31C16284748780-19d75b9d0-b137-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use omeprazole delayed-release capsules safely and effectively. See full prescribing information for omeprazole delayed-release capsules. Omeprazole Delayed-Release Capsules, USP Initial U.S. Approval: 1989
52959-722-902020-01-31C16284748780-19d75b9d0-b137-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use omeprazole delayed-release capsules safely and effectively. See full prescribing information for omeprazole delayed-release capsules. Omeprazole Delayed-Release Capsules, USP Initial U.S. Approval: 1989

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-722-15Omeprazole15 in 1 BOTTLECAPSULE, DELAYED RELEASE153
52959-722-20Omeprazole20 in 1 BOTTLECAPSULE, DELAYED RELEASE203
52959-722-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE303
52959-722-60Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE603
52959-722-90Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-722-15EA - Each52959-7224cf9167c-b95b-4291-a01a-b9034dc50dd612012-07-24
52959-722-20EA - Each52959-7229871f5fa-b67f-4614-a1a5-05a6a715f48512012-07-24
52959-722-30EA - Each52959-722bf756c8b-a8f8-42fc-9bd1-202d438593b912012-07-24
52959-722-60EA - Each52959-722473a324c-4ba7-423b-a941-46f48873950212012-07-24
52959-722-90EA - Each52959-722ebea40b4-ed1b-46de-b0dc-544e7083135712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]3
OMEPRAZOLEACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]3
AMMONIAINACTIVE INGREDIENT5138Q19F1XOMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]3
DIBUTYL SEBACATEINACTIVE INGREDIENT4W5IH7FLNYOMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]3
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BOMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]3
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1SOMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]3
GELATININACTIVE INGREDIENT2G86QN327LOMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]3
METHACRYLIC ACIDINACTIVE INGREDIENT1CS02G8656OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]3
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPOMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UOMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]3
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-722OMEPRAZOLE CAPSULE, DELAYED RELEASE [H.J. HARKINS COMPANY, INC.]3Legacy NDC, 5 package rows20120425_8750bc89-340d-4abf-b0b8-b83012ab7cae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN8750bc89-340d-4abf-b0b8-b83012ab7cae3
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD8750bc89-340d-4abf-b0b8-b83012ab7cae3
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY8750bc89-340d-4abf-b0b8-b83012ab7cae3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-722-155295907221515 in 1 BOTTLEHistorical
52959-722-205295907222020 in 1 BOTTLEHistorical
52959-722-305295907223030 in 1 BOTTLEHistorical
52959-722-605295907226060 in 1 BOTTLEHistorical
52959-722-905295907229090 in 1 BOTTLEHistorical