FDA.reportPublic FDA data

OMEPRAZOLE

Product NDC
71610-688
11-digit product format
716100688
Labeler code
71610
Product ID
71610-688_1ac7526d-c24f-66d3-e063-6294a90a42d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OMEPRAZOLE
Dosage form
CAPSULE, DELAYED RELEASE PELLETS
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA203481
Marketing category
ANDA
Marketing start
2017-07-03
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
71610-688-30OMEPRAZOLE30 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS302
71610-688-43OMEPRAZOLE1300 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS13002
71610-688-53OMEPRAZOLE60 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS602
71610-688-58OMEPRAZOLE650 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS6502
71610-688-60OMEPRAZOLE90 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS902
71610-688-80OMEPRAZOLE180 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS1802
71610-688-87OMEPRAZOLE2400 in 1 BOTTLECAPSULE, DELAYED RELEASE PELLETS24002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-688-43EA - Each71610-688790431d6-1e1f-403c-98fc-aa9b881fdc3012024-08-12
71610-688-53EA - Each71610-6889a1550a0-2c56-4141-8633-7086637969b312024-01-04
71610-688-58EA - Each71610-6889043f797-20b3-4c81-be39-7e8ae880de9c12024-08-12
71610-688-60EA - Each71610-6884c820d2c-9cec-4729-9f08-84766cecefcb12024-01-04
71610-688-80EA - Each71610-688292b68da-59f2-4eb4-a41f-db8fa1ddd6c012023-12-05
71610-688-87EA - Each71610-688db57df60-5b43-4f78-a8f7-bcd2ab27f63c12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-688OMEPRAZOLE CAPSULE, DELAYED RELEASE PELLETS [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Current NDC, 7 package rows20240625_3e99b78b-7fb8-4514-a3db-58e59cd429d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200329omeprazole 40 MG Delayed Release Oral CapsulePSN3e99b78b-7fb8-4514-a3db-58e59cd429d82
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD3e99b78b-7fb8-4514-a3db-58e59cd429d82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-688-307161006883030 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-30) 2023-01-20NoNoHistorical
71610-688-43716100688431300 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-43) 2024-06-10NoNoHistorical
71610-688-537161006885360 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-53) 2023-01-20NoNoHistorical
71610-688-5871610068858650 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-58) 2024-06-10NoNoHistorical
71610-688-607161006886090 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-60) 2023-01-20NoNoHistorical
71610-688-8071610068880180 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-80) 2023-01-20NoNoHistorical
71610-688-87716100688872400 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71610-688-87) 2024-06-10NoNoHistorical