FDA.reportPublic FDA data

Omeprazole

Product NDC
50090-3876
11-digit product format
500903876
Labeler code
50090
Product ID
50090-3876_bf1f317f-2f83-4725-915a-e59cc855ce2b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA091672
Marketing category
ANDA
Marketing start
2014-10-31
Substance
OMEPRAZOLE
Active strength
20 mg/1
Pharmacologic classes
Cytochrome P450 2C19 Inhibitors [MoA], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Omeprazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9
Rxcui198051

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
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3876-02023-02-07C16284748780-1f386c649-e338-0266-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
50090-3876-22023-02-07C16284748780-1f386c649-e338-0266-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
50090-3876-32023-02-07C16284748780-1f386c649-e338-0266-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
50090-3876-42023-02-07C16284748780-1f386c649-e338-0266-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
50090-3876-52023-02-07C16284748780-1f386c649-e338-0266-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
50090-3876-62023-02-07C16284748780-1f386c649-e338-0266-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
50090-3876-72023-02-07C16284748780-1f386c649-e338-0266-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
50090-3876-82023-02-07C16284748780-1f386c649-e338-0266-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
50090-3876-02023-01-30C16284748780-1f386c649-e338-0266-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
50090-3876-22023-01-30C16284748780-1f386c649-e338-0266-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
50090-3876-32023-01-30C16284748780-1f386c649-e338-0266-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
50090-3876-42023-01-30C16284748780-1f386c649-e338-0266-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
50090-3876-52023-01-30C16284748780-1f386c649-e338-0266-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
50090-3876-62023-01-30C16284748780-1f386c649-e338-0266-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
50090-3876-72023-01-30C16284748780-1f386c649-e338-0266-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
50090-3876-82023-01-30C16284748780-1f386c649-e338-0266-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
50090-3876-0Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3012
50090-3876-2Omeprazole15 in 1 BOTTLECAPSULE, DELAYED RELEASE1512
50090-3876-3Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE6012
50090-3876-4Omeprazole20 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE2012
50090-3876-5Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE9012
50090-3876-6Omeprazole200 in 1 BOTTLECAPSULE, DELAYED RELEASE20012
50090-3876-7Omeprazole180 in 1 BOTTLECAPSULE, DELAYED RELEASE18012
50090-3876-8Omeprazole7 in 1 BOTTLECAPSULE, DELAYED RELEASE712

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3876-0EA - Each50090-3876d5063591-0861-4311-8422-24ed174aa84712021-11-09
50090-3876-2EA - Each50090-38769e1e5d34-2af1-44c7-895b-8e0e0e1a9b3712021-11-09
50090-3876-3EA - Each50090-38765c31fd51-4432-454d-9266-391b1bfbb3ba12021-11-09
50090-3876-4EA - Each50090-3876306b414e-ce8d-4541-ac95-7ec1831f0a1512021-11-09
50090-3876-5EA - Each50090-3876ce7df574-9a67-44b7-ad40-a2f2b282c58d12021-08-05
50090-3876-6EA - Each50090-387666437f6b-1e6b-40ee-a41b-d541e48515b312021-11-09
50090-3876-7EA - Each50090-38767f6fc645-4f88-4f67-a2d4-0cc0c5ac1b8e12021-11-09
50090-3876-8EA - Each50090-3876e48b6bba-8585-4a8b-ab64-cc10237e681112021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3876OMEPRAZOLE CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 8 package rows20230328_5bda70ae-c3f6-450b-892f-6814795dd6ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN5bda70ae-c3f6-450b-892f-6814795dd6ca12
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD5bda70ae-c3f6-450b-892f-6814795dd6ca12
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY5bda70ae-c3f6-450b-892f-6814795dd6ca12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3876-05009038760030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-3876-0) 2018-11-280000-00-00NoNoCurrent
50090-3876-25009038760215 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-3876-2) 2018-11-280000-00-00NoNoCurrent
50090-3876-35009038760360 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-3876-3) 2018-11-280000-00-00NoNoCurrent
50090-3876-45009038760420 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (50090-3876-4) 2014-11-280000-00-00NoNoCurrent
50090-3876-55009038760590 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-3876-5) 2018-11-280000-00-00NoNoCurrent
50090-3876-650090387606200 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-3876-6) 2018-11-280000-00-00NoNoCurrent
50090-3876-750090387607180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-3876-7) 2018-11-280000-00-00NoNoCurrent
50090-3876-8500903876087 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-3876-8) 2018-11-280000-00-00NoNoCurrent