FDA.reportPublic FDA data

Omeprazole

Product NDC
71205-501
11-digit product format
712050501
Labeler code
71205
Product ID
71205-501_dc02ffef-7695-49cb-824c-f9a8f6bc00bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA091672
Marketing category
ANDA
Marketing start
2014-10-31
Substance
OMEPRAZOLE
Active strength
10 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
OMEPRAZOLE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9
Rxcui199119

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
71205-501-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE303
71205-501-60Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE603
71205-501-90Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-501-30EA - Each71205-50116348aa9-bf99-4694-960d-4f41dfaeb1b312021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-501OMEPRAZOLE CAPSULE, DELAYED RELEASE [PROFICIENT RX LP]3Current NDC, Legacy NDC, 3 package rows20230211_a53ea447-add5-4ed5-aa7e-975b13d90e75.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199119omeprazole 10 MG Delayed Release Oral CapsulePSNa53ea447-add5-4ed5-aa7e-975b13d90e753
199119omeprazole 10 MG Delayed Release Oral CapsuleSCDa53ea447-add5-4ed5-aa7e-975b13d90e753
199119omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral CapsuleSYa53ea447-add5-4ed5-aa7e-975b13d90e753

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-501-307120505013030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-501-30) 2020-11-040000-00-00NoNoCurrent
71205-501-607120505016060 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-501-60) 2020-11-040000-00-00NoNoCurrent
71205-501-907120505019090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71205-501-90) 2020-11-040000-00-00NoNoCurrent