FDA.reportPublic FDA data

Omeprazole

Product NDC
21130-991
11-digit product format
211300991
Labeler code
21130
Product ID
21130-991_1a05a724-635a-49fa-a890-85363fd43a27
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Living Better Brands LLC
Application
ANDA207891
Marketing category
ANDA
Marketing start
2019-06-01
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
Rxcui402014

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
21130-991-28Omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE21
21130-991-28Omeprazole14 in 1 BLISTER PACKTABLET, DELAYED RELEASE141
21130-991-44Omeprazole14 in 1 BLISTER PACKTABLET, DELAYED RELEASE141
21130-991-44Omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-991OMEPRAZOLE TABLET, DELAYED RELEASE [LIVING BETTER BRANDS LLC]1Current NDC, 4 package rows20240815_1d500e2d-395b-437e-a95c-3922a71a0956.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN1d500e2d-395b-437e-a95c-3922a71a09561
402014omeprazole 20 MG Delayed Release Oral TabletSCD1d500e2d-395b-437e-a95c-3922a71a09561
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY1d500e2d-395b-437e-a95c-3922a71a09561

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21130-991-28211300991282 BLISTER PACK in 1 CARTON (21130-991-28) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK2 blister pack2019-06-01NoNoCurrent
21130-991-44211300991441 BLISTER PACK in 1 CARTON (21130-991-44) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2019-06-01NoNoCurrent