FDA.reportPublic FDA data

basic care omeprazole

Product NDC
72288-023
11-digit product format
722880023
Labeler code
72288
Product ID
72288-023_51fc32a9-aa60-4835-a89b-1d28cb421a84
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole magnesium
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA216096
Marketing category
ANDA
Marketing start
2023-02-22
Substance
OMEPRAZOLE MAGNESIUM
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
OMEPRAZOLE MAGNESIUM20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii426QFE7XLK
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
72288-023-01basic care omeprazole14 in 1 BOTTLECAPSULE, DELAYED RELEASE143
72288-023-03basic care omeprazole3 in 1 CARTONCAPSULE, DELAYED RELEASE33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-023BASIC CARE OMEPRAZOLE (OMEPRAZOLE MAGNESIUM) CAPSULE, DELAYED RELEASE [AMAZON.COM SERVICES LLC]3Current NDC, 2 package rows20240912_a4627be3-9845-428d-b3b1-c3096ae3d9b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198051omeprazole 20 MG Delayed Release Oral CapsulePSNa4627be3-9845-428d-b3b1-c3096ae3d9b43
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDa4627be3-9845-428d-b3b1-c3096ae3d9b43
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYa4627be3-9845-428d-b3b1-c3096ae3d9b43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72288-023-017228800230114 in 1 BOTTLEHistorical
72288-023-03722880023033 BOTTLE in 1 CARTON (72288-023-03) / 14 CAPSULE, DELAYED RELEASE in 1 BOTTLE (72288-023-01) 3 bottle2023-02-22NoNoCurrent