Omeprazole

These highlights do not include all the information needed to use omeprazole delayed-release capsules safely and effectively. See full prescribing information for omeprazole delayed-release capsules. OMEPRAZOLE Delayed-Release Capsules USP Initial U.S. Approval: 1989

Approved

Approval ID

92201fb1-4570-42db-8da3-3b8c0e291d32

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 21, 2023

Manufacturers

FDA

Lannett Company, Inc.

DUNS: 006422406

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

omeprazole

PRODUCT DETAILS

NDC Product Code62175-136

Application NumberANDA075410

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateApril 21, 2023

Generic Nameomeprazole

INGREDIENTS (20)

OMEPRAZOLEActive

Quantity: 40 mg in 1 1

Code: KG60484QX9

Classification: ACTIB

CROSPOVIDONEInactive

Code: 2S7830E561

Classification: IACT

GLYCERYL DIBEHENATEInactive

Code: R8WTH25YS2

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

ALUMINUM CHLOROHYDREX PROPYLENE GLYCOLInactive

Code: PGG6VG42HP

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

omeprazole

PRODUCT DETAILS

NDC Product Code62175-118

Application NumberANDA075410

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateApril 21, 2023

Generic Nameomeprazole

INGREDIENTS (20)

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

CROSPOVIDONEInactive

Code: 2S7830E561

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

FERRIC OXIDE YELLOWInactive

Code: EX438O2MRT

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

ALUMINUM CHLOROHYDREX PROPYLENE GLYCOLInactive

Code: PGG6VG42HP

Classification: IACT

OMEPRAZOLEActive

Quantity: 20 mg in 1 1

Code: KG60484QX9

Classification: ACTIB

GLYCERYL DIBEHENATEInactive

Code: R8WTH25YS2

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

omeprazole

PRODUCT DETAILS

NDC Product Code62175-114

Application NumberANDA075410

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateApril 21, 2023

Generic Nameomeprazole

INGREDIENTS (19)

CROSPOVIDONEInactive

Code: 2S7830E561

Classification: IACT

GLYCERYL DIBEHENATEInactive

Code: R8WTH25YS2

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WO

Classification: IACT

OMEPRAZOLEActive

Quantity: 10 mg in 1 1

Code: KG60484QX9

Classification: ACTIB

METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive

Code: 74G4R6TH13

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

GELATINInactive

Code: 2G86QN327L

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

BUTYL ALCOHOLInactive

Code: 8PJ61P6TS3

Classification: IACT

ISOPROPYL ALCOHOLInactive

Code: ND2M416302

Classification: IACT

ALUMINUM CHLOROHYDREX PROPYLENE GLYCOLInactive

Code: PGG6VG42HP

Classification: IACT

ALCOHOLInactive

Code: 3K9958V90M

Classification: IACT

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Omeprazole

Products 3

omeprazole

PRODUCT DETAILS

INGREDIENTS (20)

omeprazole

PRODUCT DETAILS

INGREDIENTS (20)

omeprazole

PRODUCT DETAILS

INGREDIENTS (19)

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