Omeprazole

Product NDC
62175-136
11-digit product format
621750136
Labeler code
62175
Product ID
62175-136_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
2009-01-23
Substance
OMEPRAZOLE
Active strength
40 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
OMEPRAZOLE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiKG60484QX9
Rxcui198051, 199119, 200329

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62175-136-32Omeprazole30 in 1 BOTTLECAPSULE, DELAYED RELEASE3050
62175-136-37Omeprazole100 in 1 BOTTLECAPSULE, DELAYED RELEASE10050
62175-136-43Omeprazole1000 in 1 BOTTLECAPSULE, DELAYED RELEASE100050
62175-136-46Omeprazole90 in 1 BOTTLECAPSULE, DELAYED RELEASE9050
62175-136-49Omeprazole36000 in 1 DRUMCAPSULE, DELAYED RELEASE3600050

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62175-136-32EA - Each62175-1361a5a1f98-e561-4ca9-a588-0fb7782acf4512012-07-24
62175-136-37EA - Each62175-1360c41e231-8f2a-4e3f-b8af-6206e6047b5212012-07-24
62175-136-43EA - Each62175-1368cdd64dd-0726-4e89-aa3b-6902c171877712012-07-24

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 [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
OMEPRAZOLEACTIVE MOIETYKG60484QX9OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MOMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
ALUMINUM CHLOROHYDREX PROPYLENE GLYCOLINACTIVE INGREDIENTPGG6VG42HPOMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
AMMONIAINACTIVE INGREDIENT5138Q19F1XOMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKOMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
GELATININACTIVE INGREDIENT2G86QN327LOMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)INACTIVE INGREDIENT74G4R6TH13OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SHELLACINACTIVE INGREDIENT46N107B71OOMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JOMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UOMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMOMEPRAZOLE CAPSULE, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62175-136OMEPRAZOLE CAPSULE, DELAYED RELEASE [LANNETT COMPANY, INC.]50Current NDC, Legacy NDC, 5 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
200329omeprazole 40 MG Delayed Release Oral CapsulePSNed9895ae-3d18-434c-8b56-47bccdc8fe6d50
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 CapsuleSCDed9895ae-3d18-434c-8b56-47bccdc8fe6d50
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
200329omeprazole 40 MG Delayed Release Oral CapsulePSN0d3e1664-078f-4761-9fe2-fee36d6262f110
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD0d3e1664-078f-4761-9fe2-fee36d6262f110
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 CapsulePSN9786b04f-f827-460b-91bc-c0ac967f95dd5
200329omeprazole 40 MG Delayed Release Oral CapsulePSN5aba19da-663f-4901-94e2-f438dba4841f5
200329omeprazole 40 MG Delayed Release Oral CapsulePSN1318a1c1-222d-471a-92d6-3632c82fb9995
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 CapsuleSCD9786b04f-f827-460b-91bc-c0ac967f95dd5
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD5aba19da-663f-4901-94e2-f438dba4841f5
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD1318a1c1-222d-471a-92d6-3632c82fb9995
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
200329omeprazole 40 MG Delayed Release Oral CapsulePSN716841e8-83b7-4f0c-82c1-77a19cbef69f3
200329omeprazole 40 MG Delayed Release Oral CapsulePSN8991d464-7abc-4350-e053-2995a90a4ea73
200329omeprazole 40 MG Delayed Release Oral CapsulePSN4b188d97-f1b3-468d-9818-b8333bf24b5a3
200329omeprazole 40 MG Delayed Release Oral CapsulePSN1ba0fa57-b5a5-4e6a-9902-654d3aefc71f3
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD8991d464-7abc-4350-e053-2995a90a4ea73
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD716841e8-83b7-4f0c-82c1-77a19cbef69f3
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD4b188d97-f1b3-468d-9818-b8333bf24b5a3
200329omeprazole 40 MG Delayed Release Oral CapsuleSCD1ba0fa57-b5a5-4e6a-9902-654d3aefc71f3
198051omeprazole 20 MG Delayed Release Oral CapsulePSNa140eda6-78ab-b5fc-e053-2a95a90a0d901
200329omeprazole 40 MG Delayed Release Oral CapsulePSNa140eda6-78ab-b5fc-e053-2a95a90a0d901
200329omeprazole 40 MG Delayed Release Oral CapsulePSNf03f6191-45cd-4c20-8bd5-783cb28d26c81
198051omeprazole 20 MG Delayed Release Oral CapsuleSCDa140eda6-78ab-b5fc-e053-2a95a90a0d901
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDa140eda6-78ab-b5fc-e053-2a95a90a0d901
200329omeprazole 40 MG Delayed Release Oral CapsuleSCDf03f6191-45cd-4c20-8bd5-783cb28d26c81
198051omeprazole 20 MG (as omeprazole magnesium 20.6 MG) Delayed Release Oral CapsuleSYa140eda6-78ab-b5fc-e053-2a95a90a0d901

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62175-136-326217501363230 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62175-136-32) 2009-01-230000-00-00NoNoCurrent
62175-136-3762175013637100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62175-136-37) 2009-01-230000-00-00NoNoCurrent
62175-136-43621750136431000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62175-136-43) 2009-01-230000-00-00NoNoCurrent
62175-136-466217501364690 CAPSULE, DELAYED RELEASE in 1 BOTTLE (62175-136-46) 2009-01-230000-00-00NoNoCurrent
62175-136-496217501364936000 CAPSULE, DELAYED RELEASE in 1 DRUM (62175-136-49) 2009-01-230000-00-00NoNoCurrent