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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51407-303
Application NumberANDA075410
Product Classification
M
Marketing Category
C73584
G
Generic Name
omeprazole
Product Specifications
Route of AdministrationORAL
Effective DateOctober 16, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51407-256
Application NumberANDA075410
Product Classification
M
Marketing Category
C73584
G
Generic Name
omeprazole
Product Specifications
Route of AdministrationORAL
Effective DateOctober 16, 2023
FDA Product Classification
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