FDA.reportPublic FDA data

Omeprazole

Product NDC
0363-1607
11-digit product format
003631607
Labeler code
0363
Product ID
0363-1607_663561b1-18c8-7edf-9559-d226dc32a683
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Walgreens Company
Application
ANDA207740
Marketing category
ANDA
Marketing start
2020-01-15
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
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
0363-1607-14Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE143
0363-1607-28Omeprazole2 in 1 CARTONTABLET, DELAYED RELEASE23
0363-1607-42Omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE33

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-1607OMEPRAZOLE TABLET, DELAYED RELEASE [WALGREENS COMPANY]3Current NDC, Legacy NDC, 3 package rows20241112_5e2994fc-8f44-f6e4-71fe-44a215aa93a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN5e2994fc-8f44-f6e4-71fe-44a215aa93a93
402014omeprazole 20 MG Delayed Release Oral TabletSCD5e2994fc-8f44-f6e4-71fe-44a215aa93a93
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY5e2994fc-8f44-f6e4-71fe-44a215aa93a93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-1607-140036316071414 TABLET, DELAYED RELEASE in 1 BOTTLE (0363-1607-14) 2020-01-150000-00-00NoNoCurrent
0363-1607-28003631607282 BOTTLE in 1 CARTON (0363-1607-28) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (0363-1607-14) 2 bottle2020-01-150000-00-00NoNoCurrent
0363-1607-42003631607423 BOTTLE in 1 CARTON (0363-1607-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE (0363-1607-14) 3 bottle2020-01-150000-00-00NoNoCurrent