Omeprazole
Omeprazole delayed-release capsules. 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
9edf9c65-c5cc-be0f-e053-2a95a90a4a5c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 16, 2023
Manufacturers
FDA
Golden State Medical Supply, Inc.
DUNS: 603184490
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
omeprazole
PRODUCT DETAILS
NDC Product Code51407-303
Application NumberANDA075410
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 16, 2023
Generic Nameomeprazole
INGREDIENTS (20)
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ALUMINUM CHLOROHYDREX PROPYLENE GLYCOLInactive
Code: PGG6VG42HP
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
OMEPRAZOLEActive
Quantity: 40 mg in 1 1
Code: KG60484QX9
Classification: ACTIB
omeprazole
PRODUCT DETAILS
NDC Product Code51407-256
Application NumberANDA075410
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 16, 2023
Generic Nameomeprazole
INGREDIENTS (20)
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
OMEPRAZOLEActive
Quantity: 20 mg in 1 1
Code: KG60484QX9
Classification: ACTIB
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
GLYCERYL DIBEHENATEInactive
Code: R8WTH25YS2
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
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
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT