FDA.reportPublic FDA data

Omeprazole

Product NDC
68071-3733
11-digit product format
680713733
Labeler code
68071
Product ID
68071-3733_3ff501eb-5ae4-8824-e063-6394a90ac58e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA078490
Marketing category
ANDA
Marketing start
2014-03-01
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
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
68071-3733-2Omeprazole20 in 1 BOTTLECAPSULE, DELAYED RELEASE205
68071-3733-3Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE305
68071-3733-6Omeprazole60 in 1 BOTTLECAPSULE, DELAYED RELEASE605
68071-3733-9Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3733OMEPRAZOLE CAPSULE, DELAYED RELEASE [NUCARE PHARMACEUTICALS, INC.]4Current NDC, 4 package rows20250305_28515ff8-379d-5356-e063-6394a90af3f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSN28515ff8-379d-5356-e063-6394a90af3f35
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD28515ff8-379d-5356-e063-6394a90af3f35
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY28515ff8-379d-5356-e063-6394a90af3f35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3733-26807137330220 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-3733-2) 2025-09-29NoNoCurrent
68071-3733-36807137330330 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-3733-3) 2025-01-14NoNoCurrent
68071-3733-66807137330660 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-3733-6) 2025-03-03NoNoCurrent
68071-3733-96807137330990 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-3733-9) 2024-12-02NoNoCurrent