FDA.reportPublic FDA data

Omeprazole

Product NDC
62175-114
11-digit product format
621750114
Labeler code
62175
Product ID
62175-114_e786b865-dc62-4018-9cb1-7056b7ca2cde
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
omeprazole
Dosage form
CAPSULE, DELAYED RELEASE
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA075410
Marketing category
ANDA
Marketing start
2003-09-03
Substance
OMEPRAZOLE
Active strength
10 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
OMEPRAZOLE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9
Rxcui198051, 199119, 200329

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62175-114-32Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3050
62175-114-37Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE10050
62175-114-46Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE9050
62175-114-49Omeprazole72000 in 1 DRUMCAPSULE, DELAYED RELEASE7200050

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62175-114-32EA - Each62175-114b3589406-936c-4307-b0e9-75fb2fbb07f112012-07-24
62175-114-37EA - Each62175-1141c5c1975-21eb-4dad-a97b-27297fe19c9112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
OMEPRAZOLEACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
ALCOHOLINACTIVE INGREDIENT3K9958V90MOMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
ALUMINUM CHLOROHYDREX PROPYLENE GLYCOLINACTIVE INGREDIENTPGG6VG42HPOMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
AMMONIAINACTIVE INGREDIENT5138Q19F1XOMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3OMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
GELATININACTIVE INGREDIENT2G86QN327LOMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2OMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302OMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13OMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
SHELLACINACTIVE INGREDIENT46N107B71OOMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
TALCINACTIVE INGREDIENT7SEV7J4R1UOMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE, DELAYED RELEASE [KREMERS URBAN PHARMACEUTICALS INC.]23
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
OMEPRAZOLEACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
ALCOHOLINACTIVE INGREDIENT3K9958V90MOMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
ALUMINUM CHLOROHYDREX PROPYLENE GLYCOLINACTIVE INGREDIENTPGG6VG42HPOMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
AMMONIAINACTIVE INGREDIENT5138Q19F1XOMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3OMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
GELATININACTIVE INGREDIENT2G86QN327LOMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2OMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302OMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13OMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
SHELLACINACTIVE INGREDIENT46N107B71OOMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
TALCINACTIVE INGREDIENT7SEV7J4R1UOMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]5
OMEPRAZOLEACTIVE INGREDIENTKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
OMEPRAZOLEACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
GELATININACTIVE INGREDIENT2G86QN327LOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
GLYCERYL BEHENATEINACTIVE INGREDIENTR8WTH25YS2OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
SHELLACINACTIVE INGREDIENT46N107B71OOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE, DELAYED RELEASE [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62175-114OMEPRAZOLE CAPSULE, DELAYED RELEASE [LANNETT COMPANY, INC.]50Current NDC, Legacy NDC, 4 package rows20230429_92201fb1-4570-42db-8da3-3b8c0e291d32.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199119omeprazole 10 MG Delayed Release Oral CapsulePSN92201fb1-4570-42db-8da3-3b8c0e291d3250
198051omeprazole 20 MG Delayed Release Oral CapsulePSN92201fb1-4570-42db-8da3-3b8c0e291d3250
200329omeprazole 40 MG Delayed Release Oral CapsulePSN92201fb1-4570-42db-8da3-3b8c0e291d3250
199119omeprazole 10 MG Delayed Release Oral CapsuleSCD92201fb1-4570-42db-8da3-3b8c0e291d3250
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD92201fb1-4570-42db-8da3-3b8c0e291d3250
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD92201fb1-4570-42db-8da3-3b8c0e291d3250
199119omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral CapsuleSY92201fb1-4570-42db-8da3-3b8c0e291d3250
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY92201fb1-4570-42db-8da3-3b8c0e291d3250
199119omeprazole 10 MG Delayed Release Oral CapsulePSN5aba19da-663f-4901-94e2-f438dba4841f5
198051omeprazole 20 MG Delayed Release Oral CapsulePSN5aba19da-663f-4901-94e2-f438dba4841f5
200329omeprazole 40 MG Delayed Release Oral CapsulePSN5aba19da-663f-4901-94e2-f438dba4841f5
199119omeprazole 10 MG Delayed Release Oral CapsuleSCD5aba19da-663f-4901-94e2-f438dba4841f5
198051omeprazole 20 MG Delayed Release Oral CapsuleSCD5aba19da-663f-4901-94e2-f438dba4841f5
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD5aba19da-663f-4901-94e2-f438dba4841f5
199119omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral CapsuleSY5aba19da-663f-4901-94e2-f438dba4841f5
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSY5aba19da-663f-4901-94e2-f438dba4841f5
199119omeprazole 10 MG Delayed Release Oral CapsulePSNd58c0b66-475f-46b3-949d-cda5343e72391
198051omeprazole 20 MG Delayed Release Oral CapsulePSNd58c0b66-475f-46b3-949d-cda5343e72391
199119omeprazole 10 MG Delayed Release Oral CapsuleSCDd58c0b66-475f-46b3-949d-cda5343e72391
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDd58c0b66-475f-46b3-949d-cda5343e72391
199119omeprazole (as omeprazole magnesium) 10 MG Delayed Release Oral CapsuleSYd58c0b66-475f-46b3-949d-cda5343e72391
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYd58c0b66-475f-46b3-949d-cda5343e72391

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62175-114-326217501143230 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62175-114-32) 2003-09-030000-00-00NoNoCurrent
62175-114-3762175011437100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62175-114-37) 2003-09-030000-00-00NoNoCurrent
62175-114-466217501144690 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62175-114-46) 2003-09-030000-00-00NoNoCurrent
62175-114-496217501144972000 CAPSULE, DELAYED RELEASE in 1 DRUM (62175-114-49) 2003-09-030000-00-00NoNoCurrent