FDA.reportPublic FDA data

Omeprazole

Product NDC
46122-739
11-digit product format
461220739
Labeler code
46122
Product ID
46122-739_0c214fe9-7d95-39e0-0526-2d257f47695e
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
AMERISOURCEBERGEN DRUG CORPORATION
Application
ANDA207740
Marketing category
ANDA
Marketing start
2018-11-06
Marketing end
2027-03-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Omeprazole

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
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
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
46122-739-03Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE143
46122-739-03Omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE23
46122-739-04Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE143
46122-739-04Omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE33
46122-739-74Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE143
46122-739-74Omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46122-739OMEPRAZOLE TABLET, DELAYED RELEASE [AMERISOURCEBERGEN DRUG CORPORATION]2Current NDC, 6 package rows20241112_0521c51b-d113-7e35-f1a6-c4495a2bcfcc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN0521c51b-d113-7e35-f1a6-c4495a2bcfcc3
402014omeprazole 20 MG Delayed Release Oral TabletSCD0521c51b-d113-7e35-f1a6-c4495a2bcfcc3
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY0521c51b-d113-7e35-f1a6-c4495a2bcfcc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46122-739-034612207390314 in 1 BOTTLEHistorical
46122-739-04461220739043 BOTTLE in 1 CARTON (46122-739-04) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2023-08-302027-03-31NoNoHistorical
46122-739-74461220739741 BOTTLE in 1 CARTON (46122-739-74) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2023-08-302027-01-31NoNoHistorical