FDA.reportPublic FDA data

Omeprazole

Product NDC
50090-1157
11-digit product format
500901157
Labeler code
50090
Product ID
50090-1157_d88068a6-f7be-4ba4-b11b-46877bc62791
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075576
Marketing category
ANDA
Marketing start
2009-01-21
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
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1157-02023-11-29C16284748780-1f386c649-afae-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
50090-1157-12023-11-29C16284748780-1f386c649-afae-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
50090-1157-02023-01-30C16284748780-1f386c649-afae-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
50090-1157-12023-01-30C16284748780-1f386c649-afae-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
50090-1157-0Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3013
50090-1157-1Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE6013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1157-0EA - Each50090-11575e2d36b7-7c07-41aa-bd9b-b0288714c4ea12018-11-06
50090-1157-1EA - Each50090-1157d3b3993c-9f4d-4bc2-a661-128f2549b13312018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1157OMEPRAZOLE CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]13Current NDC, Legacy NDC, 2 package rows20231129_b129fe93-c8a2-4ae8-ad1b-8f9ae5779b68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSNb129fe93-c8a2-4ae8-ad1b-8f9ae5779b6813
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDb129fe93-c8a2-4ae8-ad1b-8f9ae5779b6813
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYb129fe93-c8a2-4ae8-ad1b-8f9ae5779b6813

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-1157-05009011570030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-1157-0) 2014-11-280000-00-00NoNoCurrent
50090-1157-15009011570160 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-1157-1) 2014-11-280000-00-00NoNoCurrent