FDA.reportPublic FDA data

Omeprazole

Product NDC
50090-6720
11-digit product format
500906720
Labeler code
50090
Product ID
50090-6720_6c19a1df-221e-479c-bee0-f3c8cdabd210
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078490
Marketing category
ANDA
Marketing start
2019-10-25
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
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-6720-0Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE303
50090-6720-1Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE603
50090-6720-2Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6720-1EA - Each50090-6720df04cabb-cef6-4413-a0c9-6c2f05bfd48512023-12-05
50090-6720-2EA - Each50090-672025bd71ab-4b30-4844-bde5-bc816b0d7fed12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6720OMEPRAZOLE CAPSULE, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]3Current NDC, 3 package rows20231123_8f13fd38-dc73-4072-bdc9-9474704a4121.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200329omeprazole 40 MG Delayed Release Oral CapsulePSN8f13fd38-dc73-4072-bdc9-9474704a41213
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD8f13fd38-dc73-4072-bdc9-9474704a41213

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6720-05009067200030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6720-0) 2023-10-05NoNoHistorical
50090-6720-15009067200160 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6720-1) 2023-11-15NoNoHistorical
50090-6720-25009067200290 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-6720-2) 2023-11-15NoNoHistorical