careone omeprazole

Product NDC
72476-473
11-digit product format
724760473
Labeler code
72476
Product ID
72476-473_965c30c2-5455-4f16-8fbf-2c57329806d5
Type
HUMAN OTC DRUG
Nonproprietary name
omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Retail Business Services, LLC
Application
NDA022032
Marketing category
NDA
Marketing start
2022-06-03
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
careone 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
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72476-473-01careone omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE143
72476-473-03careone omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72476-473CAREONE OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [RETAIL BUSINESS SERVICES, LLC]3Current NDC, Legacy NDC, 2 package rows20250419_063cfad8-3ca6-4b72-a4c9-512b8047bae3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN063cfad8-3ca6-4b72-a4c9-512b8047bae33
402014omeprazole 20 MG Delayed Release Oral TabletSCD063cfad8-3ca6-4b72-a4c9-512b8047bae33
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY063cfad8-3ca6-4b72-a4c9-512b8047bae33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72476-473-017247604730114 TABLET, DELAYED RELEASE in 1 BOTTLE (72476-473-01) 2022-06-030000-00-00NoNoCurrent
72476-473-03724760473033 BOTTLE in 1 CARTON (72476-473-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (72476-473-01) 3 bottle2022-06-030000-00-00NoNoCurrent