FDA.reportPublic FDA data

Omeprazole

Product NDC
71205-157
11-digit product format
712050157
Labeler code
71205
Product ID
71205-157_9ee846e2-6191-4e7c-bdbe-86f868eecad6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA075410
Marketing category
ANDA
Marketing start
2009-01-23
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
71205-157-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE305
71205-157-60Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE605
71205-157-90Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-157-60EA - Each71205-1571811c1e7-e8a5-4d24-86c9-3f74ca3d6ac712019-02-13
71205-157-90EA - Each71205-1574c63813e-ef22-4796-b1cc-7dedb3ac282112019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-157OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]5Current NDC, Legacy NDC, 3 package rows20221110_9786b04f-f827-460b-91bc-c0ac967f95dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200329omeprazole 40 MG Delayed Release Oral CapsulePSN9786b04f-f827-460b-91bc-c0ac967f95dd5
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD9786b04f-f827-460b-91bc-c0ac967f95dd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-157-307120501573030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-157-30) 2018-11-010000-00-00NoNoCurrent
71205-157-607120501576060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-157-60) 2018-11-010000-00-00NoNoCurrent
71205-157-907120501579090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-157-90) 2018-11-010000-00-00NoNoCurrent