FDA.reportPublic FDA data

omeprazole

Product NDC
0363-0007
11-digit product format
003630007
Labeler code
0363
Product ID
0363-0007_8e923ce5-8ec6-464d-9772-55a9b1213cdf
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Walgreen Company
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
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
0363-0007-01omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE147
0363-0007-03omeprazole14 in 1 BOTTLETABLET, DELAYED RELEASE147
0363-0007-03omeprazole3 in 1 CARTONTABLET, DELAYED RELEASE37

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0007-03EA - Each0363-0007194296d2-8a52-46de-ad59-3ba5733ac5dc12015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN COMPANY]1
OMEPRAZOLEACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN COMPANY]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHOMEPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN COMPANY]1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZOMEPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN COMPANY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOMEPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN COMPANY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOMEPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN COMPANY]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3AOMEPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN COMPANY]1
MONOETHANOLAMINEINACTIVE INGREDIENT5KV86114PTOMEPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN COMPANY]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5POMEPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN COMPANY]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOMEPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN COMPANY]1
SODIUM STEARATEINACTIVE INGREDIENTQU7E2XA9TGOMEPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN COMPANY]1
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIOMEPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN COMPANY]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4OMEPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN COMPANY]1
TALCINACTIVE INGREDIENT7SEV7J4R1UOMEPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN COMPANY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN COMPANY]1
TRIACETININACTIVE INGREDIENTXHX3C3X673OMEPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN COMPANY]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE, DELAYED RELEASE [WALGREEN COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0007OMEPRAZOLE TABLET, DELAYED RELEASE [WALGREEN COMPANY]7Current NDC, Legacy NDC, 3 package rows20240316_b7972f17-4a63-4d78-a181-01ea6d7d3963.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSNb7972f17-4a63-4d78-a181-01ea6d7d39637
402014omeprazole 20 MG Delayed Release Oral TabletSCDb7972f17-4a63-4d78-a181-01ea6d7d39637
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSYb7972f17-4a63-4d78-a181-01ea6d7d39637

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0007-010036300070114 TABLET, DELAYED RELEASE in 1 BOTTLE (0363-0007-01) 2015-03-250000-00-00NoNoCurrent
0363-0007-03003630007033 BOTTLE in 1 CARTON (0363-0007-03) / 14 TABLET, DELAYED RELEASE in 1 BOTTLE3 bottle2015-03-250000-00-00NoNoCurrent