PENTOXIFYLLINE
PENTOXIFYLLINE
Approved
Approval ID
8f24268f-c214-aef0-e053-2995a90a2d62
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 2, 2019
Manufacturers
FDA
Direct_Rx
DUNS: 079254320
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 Code72189-025
Application NumberANDA075191
Product Classification
M
Marketing Category
C73584
G
Generic Name
PENTOXIFYLLINE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 2, 2019
FDA Product Classification
INGREDIENTS (7)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
PENTOXIFYLLINEActive
Quantity: 400 mg in 1 1
Code: SD6QCT3TSU
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT