MedPath
FDA Product

Pentoxifylline

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Pentoxifylline

70954-668

Regulatory Information

70954-668

ANDA074878

C73584

January 15, 2024

USA

Pentoxifylline Extended-Release Tablets USPRx only

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

145588013

Active Ingredients

PENTOXIFYLLINE

Quantity: 400 mg in 1 1

Code: SD6QCT3TSU

Class Code: ACTIB

Inactive Ingredients

TALC

Code: 7SEV7J4R1U

Class Code: IACT

HYPROMELLOSE 2910 (10000 MPA.S)

Code: 0HO1H52958

Class Code: IACT

POVIDONE K30

Code: U725QWY32X

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

HYPROMELLOSE, UNSPECIFIED

Code: 3NXW29V3WO

Class Code: IACT

D&C YELLOW NO. 10 ALUMINUM LAKE

Code: CQ3XH3DET6

Class Code: IACT

MALTODEXTRIN

Code: 7CVR7L4A2D

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

FD&C YELLOW NO. 6

Code: H77VEI93A8

Class Code: IACT

Active Moieties

PENTOXIFYLLINE

Code: SD6QCT3TSU

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