FDA.reportPublic FDA data

good now omeprazole

Product NDC
82501-0915
11-digit product format
825010915
Labeler code
82501
Product ID
82501-0915_fa4938ea-ffb5-466e-8fce-4fdfdc97989e
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Gobrands, Inc
Application
NDA022032
Marketing category
NDA
Marketing start
2023-07-21
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
good now 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
82501-0915-0good now omeprazole14 in 1 CARTONTABLET, DELAYED RELEASE142
82501-0915-0good now omeprazole1 in 1 BLISTER PACKTABLET, DELAYED RELEASE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82501-0915GOOD NOW OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [GOBRANDS, INC]2Current NDC, 2 package rows20230823_0e7c4aee-2c9f-4d5c-9d47-c333bf00ba9f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN0e7c4aee-2c9f-4d5c-9d47-c333bf00ba9f2
402014omeprazole 20 MG Delayed Release Oral TabletSCD0e7c4aee-2c9f-4d5c-9d47-c333bf00ba9f2
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY0e7c4aee-2c9f-4d5c-9d47-c333bf00ba9f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82501-0915-08250109150014 BLISTER PACK in 1 CARTON (82501-0915-0) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK14 blister pack2023-07-21NoNoHistorical