FDA.reportPublic FDA data

omeprazole

Product NDC
37808-401
11-digit product format
378080401
Labeler code
37808
Product ID
37808-401_9cb203e7-86d0-4757-9a32-afd2038898a3
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
H E B
Application
NDA022032
Marketing category
NDA
Marketing start
2015-04-03
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-401-01omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE145
37808-401-01omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE15
37808-401-03omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE35
37808-401-03omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE145

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-401OMEPRAZOLE TABLET, DELAYED RELEASE [H E B]5Current NDC, Legacy NDC, 4 package rows20250123_491e3710-9a15-4b07-ae22-923bd1152ecc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSN491e3710-9a15-4b07-ae22-923bd1152ecc5
402014omeprazole 20 MG Delayed Release Oral TabletSCD491e3710-9a15-4b07-ae22-923bd1152ecc5
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSY491e3710-9a15-4b07-ae22-923bd1152ecc5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-401-01378080401011 BOTTLE in 1 CARTON (37808-401-01) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2015-04-030000-00-00NoNoCurrent
37808-401-03378080401033 BOTTLE in 1 CARTON (37808-401-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2015-04-030000-00-00NoNoCurrent