FDA.reportPublic FDA data

Omeprazole

Product NDC
71610-875
11-digit product format
716100875
Labeler code
71610
Product ID
71610-875_b877ff74-4a0b-4fc3-915b-815fa74a238c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
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
71610-875-53Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE601
71610-875-60Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE901
71610-875-70Omeprazole120 in 1 BOTTLECAPSULE, DELAYED RELEASE1201
71610-875-80Omeprazole180 in 1 BOTTLECAPSULE, DELAYED RELEASE1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-875-53EA - Each71610-8753091b452-d3a4-4f26-94a3-355ec74476a012025-05-14
71610-875-60EA - Each71610-87536da378f-2329-461d-8141-ef2861967ba212025-05-14
71610-875-70EA - Each71610-875d0472081-ab88-4a70-9337-1c502a1c45b912025-05-14
71610-875-80EA - Each71610-8759e895fb9-a0b9-4067-8ee6-7240a5c0800c12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-875OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, 4 package rows20250221_40f66cac-bc23-43f9-9966-87cce458c996.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200329omeprazole 40 MG Delayed Release Oral CapsulePSN40f66cac-bc23-43f9-9966-87cce458c9961
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD40f66cac-bc23-43f9-9966-87cce458c9961

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-875-537161008755360 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-875-53) 2025-02-06NoNoHistorical
71610-875-607161008756090 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-875-60) 2025-02-06NoNoHistorical
71610-875-7071610087570120 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-875-70) 2025-02-06NoNoHistorical
71610-875-8071610087580180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (71610-875-80) 2025-02-06NoNoHistorical