Spectracef
Spectracef® (cefditoren pivoxil) Tablets 200 mg and 400 mg
Approved
Approval ID
1c90b649-5536-417c-82cb-89663137f14f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 4, 2013
Manufacturers
FDA
Vansen Pharma Inc.
DUNS: 248565546
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
cefditoren pivoxil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code44004-801
Application NumberNDA021222
Product Classification
M
Marketing Category
C73594
G
Generic Name
cefditoren pivoxil
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 19, 2013
FDA Product Classification
INGREDIENTS (15)
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
CEFDITOREN PIVOXILActive
Quantity: 200 mg in 1 1
Code: 78THA212DH
Classification: ACTIM
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM TRIPOLYPHOSPHATEInactive
Code: 5HK03SA80J
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM CASEINATEInactive
Code: 7473P66J9E
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
Cefditoren Pivoxil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code44004-802
Application NumberNDA021222
Product Classification
M
Marketing Category
C73594
G
Generic Name
Cefditoren Pivoxil
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 19, 2013
FDA Product Classification
INGREDIENTS (10)
CEFDITOREN PIVOXILActive
Quantity: 400 mg in 1 1
Code: 78THA212DH
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM CASEINATEInactive
Code: 7473P66J9E
Classification: IACT
SODIUM TRIPOLYPHOSPHATEInactive
Code: 5HK03SA80J
Classification: IACT
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671P
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT