FDA.reportPublic FDA data

Omeprazole

Product NDC
60760-868
11-digit product format
607600868
Labeler code
60760
Product ID
60760-868_4537de52-f3e5-e186-e063-6394a90a5c7c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
St. Mary's Medical Park Pharmacy
Application
ANDA075757
Marketing category
ANDA
Marketing start
2022-03-31
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60760-868-07Omeprazole7 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE78
60760-868-30Omeprazole30 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE308
60760-868-60Omeprazole60 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE608
60760-868-90Omeprazole90 in 1 BOTTLE, PLASTICCAPSULE, DELAYED RELEASE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-868-07EA - Each60760-8688fe00484-8241-47de-9f82-f0d55cf36fd712022-06-06
60760-868-30EA - Each60760-868588c5ea8-d840-4d38-a401-4b327b19991212022-06-06
60760-868-60EA - Each60760-86806ea8d26-779a-409e-9828-b3bd915165aa12025-07-08
60760-868-90EA - Each60760-8680bab81c7-e6a7-4d7e-b306-230782a2f56012022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-868OMEPRAZOLE CAPSULE, DELAYED RELEASE [ST. MARY'S MEDICAL PARK PHARMACY]7Current NDC, Legacy NDC, 4 package rows20250523_db9f071b-85f4-061f-e053-2995a90a3ff5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSNdb9f071b-85f4-061f-e053-2995a90a3ff58
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDdb9f071b-85f4-061f-e053-2995a90a3ff58
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYdb9f071b-85f4-061f-e053-2995a90a3ff58

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-868-07607600868077 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-868-07) 2022-03-310000-00-00NoNoCurrent
60760-868-306076008683030 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-868-30) 2022-03-310000-00-00NoNoCurrent
60760-868-606076008686060 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-868-60) 2025-05-19NoNoHistorical
60760-868-906076008689090 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-868-90) 2022-03-310000-00-00NoNoCurrent