FDA.reportPublic FDA data

Omeprazole

Product NDC
50090-4932
11-digit product format
500904932
Labeler code
50090
Product ID
50090-4932_b9339814-3d20-4e8f-9572-fda4fbb0f28e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203270
Marketing category
ANDA
Marketing start
2015-08-19
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
2022-12-31
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
50090-4932-22023-01-30C16284748780-1f386c649-a546-0266-e053-dadaa90a7c1aThese 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
50090-4932-32023-01-30C16284748780-1f386c649-a546-0266-e053-dadaa90a7c1aThese 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
50090-4932-42023-01-30C16284748780-1f386c649-a546-0266-e053-dadaa90a7c1aThese 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
50090-4932-52023-01-30C16284748780-1f386c649-a546-0266-e053-dadaa90a7c1aThese 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
50090-4932-62023-01-30C16284748780-1f386c649-a546-0266-e053-dadaa90a7c1aThese 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
50090-4932-72023-01-30C16284748780-1f386c649-a546-0266-e053-dadaa90a7c1aThese 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
50090-4932-82023-01-30C16284748780-1f386c649-a546-0266-e053-dadaa90a7c1aThese 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
50090-4932-92023-01-30C16284748780-1f386c649-a546-0266-e053-dadaa90a7c1aThese 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
50090-4932-2Omeprazole15 in 1 BOTTLECAPSULE, DELAYED RELEASE153
50090-4932-3Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE603
50090-4932-4Omeprazole20 in 1 BOTTLECAPSULE, DELAYED RELEASE203
50090-4932-5Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE903
50090-4932-6Omeprazole200 in 1 BOTTLECAPSULE, DELAYED RELEASE2003
50090-4932-7Omeprazole180 in 1 BOTTLECAPSULE, DELAYED RELEASE1803
50090-4932-8Omeprazole7 in 1 BOTTLECAPSULE, DELAYED RELEASE73
50090-4932-9Omeprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE1203

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4932-5EA - Each50090-493206c31171-a2ff-40b4-acc0-f622ef09a4d312021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4932OMEPRAZOLE CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]3Legacy NDC, 8 package rows20210417_9e1d4d1e-9432-4236-a4b8-20d3fb0a0ee1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN9e1d4d1e-9432-4236-a4b8-20d3fb0a0ee13
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD9e1d4d1e-9432-4236-a4b8-20d3fb0a0ee13
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY9e1d4d1e-9432-4236-a4b8-20d3fb0a0ee13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4932-25009049320215 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-4932-2) 2020-02-260000-00-00NoNoCurrent
50090-4932-35009049320360 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-4932-3) 2020-02-260000-00-00NoNoCurrent
50090-4932-45009049320420 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-4932-4) 2020-02-260000-00-00NoNoCurrent
50090-4932-55009049320590 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-4932-5) 2020-02-260000-00-00NoNoCurrent
50090-4932-650090493206200 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-4932-6) 2020-02-260000-00-00NoNoCurrent
50090-4932-750090493207180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-4932-7) 2020-02-260000-00-00NoNoCurrent
50090-4932-8500904932087 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-4932-8) 2020-02-260000-00-00NoNoCurrent
50090-4932-950090493209120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-4932-9) 2020-02-260000-00-00NoNoCurrent