NDC Code(s) : 42291-268-90, 42291-268-50
Packager : AvKARE, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

EntacaponeEntacapone TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-268(NDC:47335-007)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ENTACAPONE(UNII: 4975G9NM6T)
(ENTACAPONE - UNII:4975G9NM6T) 		ENTACAPONE200 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
MANNITOL(UNII: 3OWL53L36A)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
HYDROGENATED COTTONSEED OIL(UNII: Z82Y2C65EA)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
GLYCERIN(UNII: PDC6A3C0OX)
SUCROSE(UNII: C151H8M554)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color orange (brownish-orange) Score no score
Shape OVAL Size 17 mm
Flavor Imprint Code T2;200
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42291-268-9090 in 1 BOTTLE Type 0: Not a Combination Product20/06/2014
2NDC:42291-268-50500 in 1 BOTTLE Type 0: Not a Combination Product20/06/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA020796 06/20/2014

PRINCIPAL DISPLAY PANEL

AvKARE

NDC 42291-268-90

Entacapone Tablets

200 mg

90 Tablets       Rx Only

Usual adult dosage: See package insert for dosage information.

Store at 25ºC (77ºF); excursions permitted to 15ºC to 30ºC (59ºF to 86ºF).

Keep this and all drugs out of the reach of children.

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

Mfg. Iss. 11/12          AV 06/14 (P)

N3   42291 26890   6

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