FDA.reportPublic FDA data

Basic Care Omeprazole

Product NDC
72288-123
11-digit product format
722880123
Labeler code
72288
Product ID
72288-123_3d759662-06ea-46b7-b26e-33f376b7e262
Type
HUMAN OTC DRUG
Nonproprietary name
omeprazole
Dosage form
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route
ORAL
Labeler
Amazon.com Services LLC
Application
NDA209400
Marketing category
NDA
Marketing start
2021-08-19
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
Basic Care Omeprazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OMEPRAZOLE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9
Rxcui2003656

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72288-123-55Basic Care Omeprazole1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING, D13
72288-123-55Basic Care Omeprazole42 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D423
72288-123-74Basic Care Omeprazole14 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D143
72288-123-74Basic Care Omeprazole1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING, D13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-123BASIC CARE OMEPRAZOLE (OMEPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [AMAZON.COM SERVICES LLC]3Current NDC, Legacy NDC, 4 package rows20250130_87a2aa9b-c681-41c7-8a59-b359efd443cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2003656omeprazole 20 MG Delayed Release Disintegrating Oral TabletPSN87a2aa9b-c681-41c7-8a59-b359efd443cb3
2003656omeprazole 20 MG Disintegrating Oral TabletSCD87a2aa9b-c681-41c7-8a59-b359efd443cb3
2003656omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Disintegrating Oral TabletSY87a2aa9b-c681-41c7-8a59-b359efd443cb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72288-123-557228801235542 BLISTER PACK in 1 CARTON (72288-123-55) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK42 blister pack2022-04-110000-00-00NoNoCurrent
72288-123-747228801237414 BLISTER PACK in 1 CARTON (72288-123-74) / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK14 blister pack2021-08-190000-00-00NoNoCurrent