FDA.reportPublic FDA data

Omeprazole

Product NDC
70700-149
11-digit product format
707000149
Labeler code
70700
Product ID
70700-149_49528611-b139-6768-e43e-bc6f26715fa3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Xiromed, LLC
Application
ANDA212977
Marketing category
ANDA
Marketing start
2019-02-20
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
Rxcui198051, 199119, 200329

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70700-149-01Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE10020
70700-149-05Omeprazole500 in 1 BOTTLECAPSULE, DELAYED RELEASE50020
70700-149-30Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3020

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70700-149OMEPRAZOLE CAPSULE, DELAYED RELEASE [XIROMED, LLC]20Current NDC, Legacy NDC, 3 package rows20250201_38bd8e13-591e-f11b-7d8a-11717c56493c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199119omeprazole 10 MG Delayed Release Oral CapsulePSN38bd8e13-591e-f11b-7d8a-11717c56493c20
198051omeprazole 20 MG Delayed Release Oral CapsulePSN38bd8e13-591e-f11b-7d8a-11717c56493c20
200329omeprazole 40 MG Delayed Release Oral CapsulePSN38bd8e13-591e-f11b-7d8a-11717c56493c20
199119omeprazole 10 MG Delayed Release Oral CapsuleSCD38bd8e13-591e-f11b-7d8a-11717c56493c20
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD38bd8e13-591e-f11b-7d8a-11717c56493c20
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD38bd8e13-591e-f11b-7d8a-11717c56493c20
199119omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral CapsuleSY38bd8e13-591e-f11b-7d8a-11717c56493c20
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY38bd8e13-591e-f11b-7d8a-11717c56493c20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70700-149-0170700014901100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70700-149-01) 2021-01-080000-00-00NoNoCurrent
70700-149-0570700014905500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70700-149-05) 2019-02-200000-00-00NoNoCurrent
70700-149-307070001493030 CAPSULE, DELAYED RELEASE in 1 BOTTLE (70700-149-30) 2019-02-200000-00-00NoNoCurrent