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, for oral use Initial U.S. Approval: 1989

Approved

Approval ID

934601b6-fbba-43c4-a8ef-7a7dfe9f9a51

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Apr 17, 2023

Manufacturers

FDA

Aurobindo Pharma Limited

DUNS: 650082092

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 Code59651-002

Application NumberANDA203270

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateApril 17, 2023

Generic NameOmeprazole

INGREDIENTS (21)

OMEPRAZOLEActive

Quantity: 20 mg in 1 1

Code: KG60484QX9

Classification: ACTIB

SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive

Code: 94255I6E2T

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

Omeprazole

PRODUCT DETAILS

NDC Product Code59651-003

Application NumberANDA203270

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateApril 17, 2023

Generic NameOmeprazole

INGREDIENTS (21)

SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive

Code: 94255I6E2T

Classification: IACT

OMEPRAZOLEActive

Quantity: 40 mg in 1 1

Code: KG60484QX9

Classification: ACTIB

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

Omeprazole

PRODUCT DETAILS

NDC Product Code59651-001

Application NumberANDA203270

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateApril 17, 2023

Generic NameOmeprazole

INGREDIENTS (21)

OMEPRAZOLEActive

Quantity: 10 mg in 1 1

Code: KG60484QX9

Classification: ACTIB

SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive

Code: 94255I6E2T

Classification: IACT

HYPROMELLOSE 2910 (5 MPA.S)Inactive

Code: R75537T0T4

Classification: IACT

MANNITOLInactive

Code: 3OWL53L36A

Classification: IACT

METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMERInactive

Code: NX76LV5T8J

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4

Classification: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8H

Classification: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JP

Classification: IACT

SODIUM LAURYL SULFATEInactive

Code: 368GB5141J

Classification: IACT

TALCInactive

Code: 7SEV7J4R1U

Classification: IACT

GELATIN, UNSPECIFIEDInactive

Code: 2G86QN327L

Classification: IACT

FERROSOFERRIC OXIDEInactive

Code: XM0M87F357

Classification: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UM

Classification: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675

Classification: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4T

Classification: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3

Classification: IACT

SHELLACInactive

Code: 46N107B71O

Classification: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671P

Classification: IACT

LACTOSE MONOHYDRATEInactive

Code: EWQ57Q8I5X

Classification: IACT

AMMONIAInactive

Code: 5138Q19F1X

Classification: IACT

AI-Powered Research

Premium Access

Omeprazole

Products 3

Omeprazole

PRODUCT DETAILS

INGREDIENTS (21)

Omeprazole

PRODUCT DETAILS

INGREDIENTS (21)

Omeprazole

PRODUCT DETAILS

INGREDIENTS (21)