OMEPRAZOLE DR
OMEPRAZOLE DR
Approved
Approval ID
c6bc8fb7-2862-464a-b7c9-e409034f072a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 31, 2023
Manufacturers
FDA
Direct Rx
DUNS: 079254320
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
OMEPRAZOLE DR
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61919-176
Application NumberANDA076048
Product Classification
M
Marketing Category
C73584
G
Generic Name
OMEPRAZOLE DR
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2023
FDA Product Classification
INGREDIENTS (17)
MAGNESIUM HYDROXIDEInactive
Code: NBZ3QY004S
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
OMEPRAZOLEActive
Quantity: 20 mg in 1 1
Code: KG60484QX9
Classification: ACTIB
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
OMEPRAZOLE DR
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61919-773
Application NumberANDA076048
Product Classification
M
Marketing Category
C73584
G
Generic Name
OMEPRAZOLE DR
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2023
FDA Product Classification
INGREDIENTS (17)
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM HYDROXIDEInactive
Code: NBZ3QY004S
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
OMEPRAZOLEActive
Quantity: 40 mg in 1 1
Code: KG60484QX9
Classification: ACTIB
SHELLACInactive
Code: 46N107B71O
Classification: IACT
OMEPRAZOLE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61919-847
Application NumberANDA091672
Product Classification
M
Marketing Category
C73584
G
Generic Name
OMEPRAZOLE
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2023
FDA Product Classification
INGREDIENTS (14)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
OMEPRAZOLEActive
Quantity: 40 mg in 1 1
Code: KG60484QX9
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, DIHYDRATEInactive
Code: 94255I6E2T
Classification: IACT
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)Inactive
Code: G4U024CQK6
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT