Omeprazole
Approved
Approval ID
a4d91dd8-10be-42e7-9088-abef4f9a3fff
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 30, 2014
Manufacturers
FDA
ReadyMeds
DUNS: 072115132
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 Code64205-620
Application NumberANDA075347
Product Classification
M
Marketing Category
C73584
G
Generic Name
Omeprazole
Product Specifications
Route of AdministrationORAL
Effective DateJune 30, 2014
FDA Product Classification
INGREDIENTS (17)
OMEPRAZOLEActive
Quantity: 20 mg in 1 1
Code: KG60484QX9
Classification: ACTIB
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)Inactive
Code: G4U024CQK6
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Omeprazole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64205-640
Application NumberANDA075347
Product Classification
M
Marketing Category
C73584
G
Generic Name
Omeprazole
Product Specifications
Route of AdministrationORAL
Effective DateJune 30, 2014
FDA Product Classification
INGREDIENTS (17)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
OMEPRAZOLEActive
Quantity: 40 mg in 1 1
Code: KG60484QX9
Classification: ACTIB
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST)Inactive
Code: G4U024CQK6
Classification: IACT
POVIDONE K90Inactive
Code: RDH86HJV5Z
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT