FDA.reportPublic FDA data

good neighbor pharmacy omeprazole

Product NDC
46122-281
11-digit product format
461220281
Labeler code
46122
Product ID
46122-281_b734d645-be14-4398-b7e2-9017c771fff1
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Amerisource Bergen
Application
NDA022032
Marketing category
NDA
Marketing start
2015-03-25
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
Rxcui402014

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46122-281-04good neighbor pharmacy omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE144
46122-281-04good neighbor pharmacy omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE34
46122-281-74good neighbor pharmacy omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE14
46122-281-74good neighbor pharmacy omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE144

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-281-04EA - Each46122-281f839fc1a-e3c5-49ea-a7e8-ab1b549648dd12018-03-08
46122-281-74EA - Each46122-281fad2429c-d4f6-4c2e-9ff4-2d0dca20680012018-03-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9GOOD NEIGHBOR PHARMACY OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [AMERISOURCE BERGEN]1
OMEPRAZOLEACTIVE MOIETYKG60484QX9GOOD NEIGHBOR PHARMACY OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [AMERISOURCE BERGEN]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHGOOD NEIGHBOR PHARMACY OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [AMERISOURCE BERGEN]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZGOOD NEIGHBOR PHARMACY OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [AMERISOURCE BERGEN]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOGOOD NEIGHBOR PHARMACY OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [AMERISOURCE BERGEN]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XGOOD NEIGHBOR PHARMACY OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [AMERISOURCE BERGEN]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AGOOD NEIGHBOR PHARMACY OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [AMERISOURCE BERGEN]1
MONOETHANOLAMINEINACTIVE INGREDIENT5KV86114PTGOOD NEIGHBOR PHARMACY OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [AMERISOURCE BERGEN]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PGOOD NEIGHBOR PHARMACY OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [AMERISOURCE BERGEN]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JGOOD NEIGHBOR PHARMACY OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [AMERISOURCE BERGEN]1
SODIUM STEARATEINACTIVE INGREDIENTQU7E2XA9TGGOOD NEIGHBOR PHARMACY OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [AMERISOURCE BERGEN]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIGOOD NEIGHBOR PHARMACY OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [AMERISOURCE BERGEN]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4GOOD NEIGHBOR PHARMACY OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [AMERISOURCE BERGEN]1
TALCINACTIVE INGREDIENT7SEV7J4R1UGOOD NEIGHBOR PHARMACY OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [AMERISOURCE BERGEN]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPGOOD NEIGHBOR PHARMACY OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [AMERISOURCE BERGEN]1
TRIACETININACTIVE INGREDIENTXHX3C3X673GOOD NEIGHBOR PHARMACY OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [AMERISOURCE BERGEN]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMGOOD NEIGHBOR PHARMACY OMEPRAZOLE (OMEPRAZOLE) CAPSULE, DELAYED RELEASE [AMERISOURCE BERGEN]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-281GOOD NEIGHBOR PHARMACY OMEPRAZOLE (OMEPRAZOLE) TABLET, DELAYED RELEASE [AMERISOURCE BERGEN]4Current NDC, Legacy NDC, 4 package rows20240427_5ee3cb79-5c0c-456f-b5d5-d5a008bbd118.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN5ee3cb79-5c0c-456f-b5d5-d5a008bbd1184
402014omeprazole 20 MG Delayed Release Oral TabletSCD5ee3cb79-5c0c-456f-b5d5-d5a008bbd1184
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY5ee3cb79-5c0c-456f-b5d5-d5a008bbd1184

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-281-04461220281043 BOTTLE in 1 CARTON (46122-281-04) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2015-03-250000-00-00NoNoCurrent
46122-281-74461220281741 BOTTLE in 1 CARTON (46122-281-74) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2015-03-270000-00-00NoNoCurrent