FDA.reportPublic FDA data

Omeprazole

Product NDC
37835-001
11-digit product format
378350001
Labeler code
37835
Product ID
37835-001_31dbc48a-ec90-e368-e063-6294a90a6c96
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
BI-MART
Application
ANDA207891
Marketing category
ANDA
Marketing start
2019-09-30
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
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
424daadb-95de-8ece-97f5-235e3f7f0001Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37835-001-14Omeprazole1 in 1 CARTONTABLET, DELAYED RELEASE14
37835-001-14Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE144
37835-001-42Omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE34
37835-001-42Omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE144

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37835-001OMEPRAZOLE TABLET, DELAYED RELEASE [BI-MART]4Current NDC, Legacy NDC, 4 package rows20250406_fb089d15-daa4-477a-be83-ecd55c3283d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSNfb089d15-daa4-477a-be83-ecd55c3283d44
402014omeprazole 20 MG Delayed Release Oral TabletSCDfb089d15-daa4-477a-be83-ecd55c3283d44
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSYfb089d15-daa4-477a-be83-ecd55c3283d44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37835-001-14378350001141 BOTTLE in 1 CARTON (37835-001-14) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE1 bottle2019-09-30NoNoHistorical
37835-001-42378350001423 BOTTLE in 1 CARTON (37835-001-42) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2019-09-300000-00-00NoNoCurrent