FDA.reportPublic FDA data

Omeprazole

Product NDC
11383-257
11-digit product format
113830257
Labeler code
11383
Product ID
11383-257_5b04f51e-2b48-492b-84b1-22e988d46720
Type
HUMAN OTC DRUG
Nonproprietary name
Omeprazole
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Weeks & Leo Co., Inc.
Application
NDA022032
Marketing category
NDA
Marketing start
2011-07-12
Marketing end
0000-00-00
Substance
OMEPRAZOLE
Active strength
20 mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11383-257-162020-01-31C16284748780-19d75b9d1-0b61-f424-e053-dadaa90a57ceOmeprazole Delayed Release Tablets, 20 mg
11383-257-432020-01-31C16284748780-19d75b9d1-0b61-f424-e053-dadaa90a57ceOmeprazole Delayed Release Tablets, 20 mg
11383-257-612020-01-31C16284748780-19d75b9d1-0b61-f424-e053-dadaa90a57ceOmeprazole Delayed Release Tablets, 20 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11383-257-16OmeprazoleDelayed Release14 in 1 BLISTER PACKTABLET, DELAYED RELEASE143
11383-257-16OmeprazoleDelayed Release1 in 1 CARTONTABLET, DELAYED RELEASE13
11383-257-43OmeprazoleDelayed Release14 in 1 BLISTER PACKTABLET, DELAYED RELEASE143
11383-257-43OmeprazoleDelayed Release3 in 1 CARTONTABLET, DELAYED RELEASE33
11383-257-61OmeprazoleDelayed Release2 in 1 CARTONTABLET, DELAYED RELEASE23
11383-257-61OmeprazoleDelayed Release14 in 1 BLISTER PACKTABLET, DELAYED RELEASE143

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9OMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]3
OMEPRAZOLEACTIVE MOIETYKG60484QX9OMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZOMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]3
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]3
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]3
HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S)INACTIVE INGREDIENT36BGF0E889OMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]3
MONOETHANOLAMINEINACTIVE INGREDIENT5KV86114PTOMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3OMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]3
SODIUM STEARATEINACTIVE INGREDIENTQU7E2XA9TGOMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]3
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIOMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UOMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]3
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11383-257OMEPRAZOLE DELAYED RELEASE (OMEPRAZOLE) TABLET, DELAYED RELEASE [WEEKS & LEO CO., INC.]3Legacy NDC, 6 package rows20130221_bb7e658c-dab5-43b3-b5c2-578948164e63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402014omeprazole 20 MG Delayed Release Oral TabletPSNbb7e658c-dab5-43b3-b5c2-578948164e633
402014omeprazole 20 MG Delayed Release Oral TabletSCDbb7e658c-dab5-43b3-b5c2-578948164e633
402014omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral TabletSYbb7e658c-dab5-43b3-b5c2-578948164e633

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
11383-257-161138302571614 in 1 BLISTER PACKHistorical
11383-257-431138302574314 in 1 BLISTER PACKHistorical
11383-257-61113830257612 in 1 CARTONHistorical