NDC Code(s) : 52125-214-02
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

PentoxifyllinePentoxifylline TABLET, FILM COATED, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-214
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PENTOXIFYLLINE(UNII: SD6QCT3TSU)
(PENTOXIFYLLINE - UNII:SD6QCT3TSU) 		PENTOXIFYLLINE400 mg
Inactive Ingredients
Ingredient Name Strength
D&C RED NO. 30(UNII: 2S42T2808B)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)(UNII: 8136Y38GY5)
HYPROMELLOSES(UNII: 3NXW29V3WO)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
POVIDONES(UNII: FZ989GH94E)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
Product Characteristics
Color purple Score no score
Shape CAPSULE (TABLET, FILM COATED, EXTENDED RELEASE) Size 16 mm
Flavor Imprint Code MYLAN;357
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-214-0230 in 1 BLISTER PACK Type 0: Not a Combination Product20/08/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074425 08/20/2012 09/12/2013

PRINCIPAL DISPLAY PANEL

DRUG: Pentoxifylline


GENERIC: Pentoxifylline


DOSAGE: TABLET, FILM COATED, EXTENDED RELEASE


ADMINSTRATION: ORAL


NDC: 52125-214-02


STRENGTH:400 mg


COLOR: purple


SHAPE: CAPSULE


SCORE: No score


SIZE: 16 mm


IMPRINT: 30


QTY: 30



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