MedPath

Pentoxifylline

PENTOXIFYLLINE Extended-Release Tablets, 400 mg

Approved
Approval ID

c28cf3c3-8c13-46c6-a051-6de99db19882

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 1, 2019

Manufacturers
FDA

Oceanside Pharmaceuticals

DUNS: 832011691

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 Code68682-101
Application NumberANDA075028
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pentoxifylline
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2019
FDA Product Classification

INGREDIENTS (5)

ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
PENTOXIFYLLINEActive
Quantity: 400 mg in 1 1
Code: SD6QCT3TSU
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT

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Pentoxifylline - FDA Drug Approval Details