FDA.reportPublic FDA data

Omeprazole

Product NDC
50436-0396
11-digit product format
504360396
Labeler code
50436
Product ID
50436-0396_7d5b7242-ef7f-4006-adfc-a8996b61597b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA091672
Marketing category
ANDA
Marketing start
2014-10-31
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
No
Listing certified through
2020-12-31
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
50436-0396-12021-01-29C16284748780-1ba0f9c33-452a-a910-e053-dadaa90a0b85These 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, for oral use Initial U.S. Approval: 1989
50436-0396-22021-01-29C16284748780-1ba0f9c33-452a-a910-e053-dadaa90a0b85These 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, for oral use Initial U.S. Approval: 1989
50436-0396-32021-01-29C16284748780-1ba0f9c33-452a-a910-e053-dadaa90a0b85These 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, for oral use Initial U.S. Approval: 1989

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0396-1Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE308
50436-0396-2Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE608
50436-0396-3Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-0396-1EA - Each50436-0396b08c4454-90a0-466e-bb15-ed2ffde21a6412018-02-20
50436-0396-2EA - Each50436-03961fab971c-b624-463e-8cee-60ce1b63d64e12018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0396OMEPRAZOLE CAPSULE, DELAYED RELEASE [UNIT DOSE SERVICES]8Legacy NDC, 3 package rows20190509_f43f6cee-7609-4ca0-a409-e4a74575a277.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0396-15043603960130 in 1 BOTTLEHistorical
50436-0396-25043603960260 in 1 BOTTLEHistorical
50436-0396-35043603960390 in 1 BOTTLEHistorical