FDA.reportPublic FDA data

Omeprazole

Product NDC
0904-6917
11-digit product format
009046917
Labeler code
0904
Product ID
0904-6917_54091ab1-10e5-4a5c-8abc-e58d24d24168
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA091352
Marketing category
ANDA
Marketing start
2012-11-23
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-6917-61Omeprazole100 in 1 CARTONCAPSULE, DELAYED RELEASE1006
0904-6917-61Omeprazole1 in 1 BLISTER PACKCAPSULE, DELAYED RELEASE16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6917OMEPRAZOLE CAPSULE, DELAYED RELEASE [MAJOR PHARMACEUTICALS]5Current NDC, Legacy NDC, 2 package rows20240518_afda9d2c-b141-4c32-a5b4-e850974b30a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSNfbd71fd8-3f36-46a1-bc76-53f6820d42a28
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDfbd71fd8-3f36-46a1-bc76-53f6820d42a28
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYfbd71fd8-3f36-46a1-bc76-53f6820d42a28
198051omeprazole 20 MG Delayed Release Oral CapsulePSNafda9d2c-b141-4c32-a5b4-e850974b30a36
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDafda9d2c-b141-4c32-a5b4-e850974b30a36
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYafda9d2c-b141-4c32-a5b4-e850974b30a36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6917-6100904691761100 BLISTER PACK in 1 CARTON (0904-6917-61) / 1 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK100 blister pack2012-11-230000-00-00NoNoCurrent