FDA.reportPublic FDA data

good neighbor pharmacy omeprazole

Product NDC
46122-616
11-digit product format
461220616
Labeler code
46122
Product ID
46122-616_99568183-6575-488b-a829-414bb8cf34a6
Type
HUMAN OTC DRUG
Nonproprietary name
omeprazole
Dosage form
TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE
Route
ORAL
Labeler
Amerisource Bergen
Application
NDA209400
Marketing category
NDA
Marketing start
2019-09-11
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 neighbor pharmacy 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
46122-616-04good neighbor pharmacy omeprazole14 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D143
46122-616-04good neighbor pharmacy omeprazole3 in 1 CARTONTABLET, ORALLY DISINTEGRATING, D33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-616GOOD NEIGHBOR PHARMACY OMEPRAZOLE (OMEPRAZOLE) TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE [AMERISOURCE BERGEN]3Current NDC, Legacy NDC, 2 package rows20250402_54fd9f84-9c67-4846-b79d-eb9e6720a315.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2003656omeprazole 20 MG Delayed Release Disintegrating Oral TabletPSN54fd9f84-9c67-4846-b79d-eb9e6720a3153
2003656omeprazole 20 MG Disintegrating Oral TabletSCD54fd9f84-9c67-4846-b79d-eb9e6720a3153
2003656omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Disintegrating Oral TabletSY54fd9f84-9c67-4846-b79d-eb9e6720a3153

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-616-04461220616043 CARTON in 1 CARTON (46122-616-04) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE in 1 BLISTER PACK3 carton2019-09-110000-00-00NoNoCurrent