FDA.reportPublic FDA data

Omeprazole

Product NDC
50090-2769
11-digit product format
500902769
Labeler code
50090
Product ID
50090-2769_c546b844-7aa5-4a17-acee-72cd27a1ef8f
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
40 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
OMEPRAZOLE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9
Rxcui200329

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2769-02023-02-06C16284748780-1f386c649-a4e8-0266-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
50090-2769-12023-02-06C16284748780-1f386c649-a4e8-0266-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
50090-2769-22023-02-06C16284748780-1f386c649-a4e8-0266-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
50090-2769-0Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3015
50090-2769-1Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE6015
50090-2769-2Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE9015
50090-2769-3Omeprazole28 in 1 BOTTLECAPSULE, DELAYED RELEASE2815

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2769-0EA - Each50090-276936b41b37-295e-4ae8-9d09-57c3fe85fe1412019-04-11
50090-2769-1EA - Each50090-2769cf2af09a-ed5a-4701-97b4-90f51abbefbd12019-04-11
50090-2769-2EA - Each50090-2769a7f022b9-97ef-4dbe-9101-d99cbc2792fe12018-09-05
50090-2769-3EA - Each50090-276979acfddb-79f4-4c2f-83c0-2c1a384a9ae112024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2769OMEPRAZOLE CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]15Current NDC, Legacy NDC, 4 package rows20240906_30e58465-c5d2-4925-85bb-53faa6135c5c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200329omeprazole 40 MG Delayed Release Oral CapsulePSN30e58465-c5d2-4925-85bb-53faa6135c5c15
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD30e58465-c5d2-4925-85bb-53faa6135c5c15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2769-05009027690030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-2769-0) 2017-01-100000-00-00NoNoCurrent
50090-2769-15009027690160 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-2769-1) 2017-01-300000-00-00NoNoCurrent
50090-2769-25009027690290 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-2769-2) 2017-01-100000-00-00NoNoCurrent
50090-2769-35009027690328 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-2769-3) 2023-12-11NoNoHistorical