FDA.reportPublic FDA data

Omeprazole

Product NDC
65841-760
11-digit product format
658410760
Labeler code
65841
Product ID
65841-760_691b64ae-e6ff-4a10-9973-886901529db0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Zydus Lifesciences Limited
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, 199119, 200329

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
65841-760-01Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE10011
65841-760-05Omeprazole500 in 1 BOTTLECAPSULE, DELAYED RELEASE50011
65841-760-06Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3011
65841-760-10Omeprazole1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100011
65841-760-16Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE9011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-760OMEPRAZOLE CAPSULE, DELAYED RELEASE [ZYDUS LIFESCIENCES LIMITED]11Current NDC, Legacy NDC, 5 package rows20241206_2aaaf0fd-7f2a-4533-b3ad-f35c6c19cca2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199119omeprazole 10 MG Delayed Release Oral CapsulePSN2aaaf0fd-7f2a-4533-b3ad-f35c6c19cca211
198051omeprazole 20 MG Delayed Release Oral CapsulePSN2aaaf0fd-7f2a-4533-b3ad-f35c6c19cca211
200329omeprazole 40 MG Delayed Release Oral CapsulePSN2aaaf0fd-7f2a-4533-b3ad-f35c6c19cca211
199119omeprazole 10 MG Delayed Release Oral CapsuleSCD2aaaf0fd-7f2a-4533-b3ad-f35c6c19cca211
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD2aaaf0fd-7f2a-4533-b3ad-f35c6c19cca211
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD2aaaf0fd-7f2a-4533-b3ad-f35c6c19cca211
199119omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral CapsuleSY2aaaf0fd-7f2a-4533-b3ad-f35c6c19cca211
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY2aaaf0fd-7f2a-4533-b3ad-f35c6c19cca211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65841-760-0165841076001100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-760-01) 2012-11-230000-00-00NoNoCurrent
65841-760-0565841076005500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-760-05) 2012-11-230000-00-00NoNoCurrent
65841-760-066584107600630 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-760-06) 2012-11-230000-00-00NoNoCurrent
65841-760-10658410760101000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-760-10) 2012-11-230000-00-00NoNoCurrent
65841-760-166584107601690 CAPSULE, DELAYED RELEASE in 1 BOTTLE (65841-760-16) 2012-11-230000-00-00NoNoCurrent