FDA.reportPublic FDA data

AMAZON BASIC CARE OMEPRAZOLE

Product NDC
72288-409
11-digit product format
722880409
Labeler code
72288
Product ID
72288-409_0e2645ca-76b7-4f38-9513-cba86dfa20a3
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Amazon.com Services LLC
Application
ANDA206877
Marketing category
ANDA
Marketing start
2024-05-15
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
AMAZON 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
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
72288-409-01AMAZON BASIC CARE OMEPRAZOLE1 in 1 CARTONTABLET, DELAYED RELEASE12
72288-409-01AMAZON BASIC CARE OMEPRAZOLE14 in 1 BLISTER PACKTABLET, DELAYED RELEASE142
72288-409-03AMAZON BASIC CARE OMEPRAZOLE14 in 1 BLISTER PACKTABLET, DELAYED RELEASE142
72288-409-03AMAZON BASIC CARE OMEPRAZOLE3 in 1 CARTONTABLET, DELAYED RELEASE32
72288-409-05AMAZON BASIC CARE OMEPRAZOLE1 in 1 CARTONTABLET, DELAYED RELEASE12
72288-409-05AMAZON BASIC CARE OMEPRAZOLE14 in 1 BOTTLETABLET, DELAYED RELEASE142
72288-409-61AMAZON BASIC CARE OMEPRAZOLE14 in 1 BOTTLETABLET, DELAYED RELEASE142
72288-409-61AMAZON BASIC CARE OMEPRAZOLE2 in 1 CARTONTABLET, DELAYED RELEASE22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72288-409AMAZON BASIC CARE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [AMAZON.COM SERVICES LLC]2Current NDC, 8 package rows20240515_10efef7c-bdf4-36cf-e063-6394a90a8c0f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN10efef7c-bdf4-36cf-e063-6394a90a8c0f2
402014omeprazole 20 MG Delayed Release Oral TabletSCD10efef7c-bdf4-36cf-e063-6394a90a8c0f2
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY10efef7c-bdf4-36cf-e063-6394a90a8c0f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72288-409-01722880409011 BLISTER PACK in 1 CARTON (72288-409-01) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK1 blister pack2024-05-15NoNoCurrent
72288-409-03722880409033 BLISTER PACK in 1 CARTON (72288-409-03) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK3 blister pack2024-05-15NoNoCurrent
72288-409-05722880409051 BOTTLE in 1 CARTON (72288-409-05) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2024-05-15NoNoCurrent
72288-409-61722880409612 BOTTLE in 1 CARTON (72288-409-61) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE2 bottle2024-05-15NoNoCurrent