Pentoxifylline
Approved
Approval ID
83d5ef4b-8b46-48b6-ae5a-9a0e493350a0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 31, 2010
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pentoxifylline
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-0758
Application NumberANDA074425
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pentoxifylline
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2010
FDA Product Classification
INGREDIENTS (13)
PENTOXIFYLLINEActive
Quantity: 400 mg in 1 1
Code: SD6QCT3TSU
Classification: ACTIB
D&C RED NO. 30Inactive
Code: 2S42T2808B
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)Inactive
Code: 8136Y38GY5
Classification: IACT
HYPROMELLOSEInactive
Code: 3NXW29V3WO
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
POLYETHYLENE GLYCOLInactive
Code: 3WJQ0SDW1A
Classification: IACT