NDC Code(s) : 50268-305-11, 50268-305-13, 50268-306-11, 50268-306-13, 50268-307-11, 50268-307-13
Packager : AvPAK

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Famciclovir Famciclovir TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-305(NDC:33342-024)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMCICLOVIR(UNII: QIC03ANI02)
(PENCICLOVIR - UNII:359HUE8FJC) 		FAMCICLOVIR125 mg
Inactive Ingredients
Ingredient Name Strength
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
LACTOSE(UNII: J2B2A4N98G)
Product Characteristics
Color WHITE Score no score
Shape ROUND (Biconvex) Size 8 mm
Flavor Imprint Code ML67
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50268-305-1330 in 1 BOX, UNIT-DOSE
1NDC:50268-305-111 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201022 05/16/2013
Famciclovir Famciclovir TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-306(NDC:33342-025)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMCICLOVIR(UNII: QIC03ANI02)
(PENCICLOVIR - UNII:359HUE8FJC) 		FAMCICLOVIR250 mg
Inactive Ingredients
Ingredient Name Strength
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
LACTOSE(UNII: J2B2A4N98G)
Product Characteristics
Color WHITE Score no score
Shape ROUND (Biconvex) Size 10 mm
Flavor Imprint Code ML70
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50268-306-1330 in 1 BOX, UNIT-DOSE
1NDC:50268-306-111 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201022 05/16/2013
Famciclovir Famciclovir TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50268-307(NDC:33342-026)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMCICLOVIR(UNII: QIC03ANI02)
(PENCICLOVIR - UNII:359HUE8FJC) 		FAMCICLOVIR500 mg
Inactive Ingredients
Ingredient Name Strength
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED(UNII: 2165RE0K14)
MAGNESIUM STEARATE(UNII: 70097M6I30)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
LACTOSE(UNII: J2B2A4N98G)
Product Characteristics
Color WHITE Score no score
Shape OVAL (Biconvex) Size 18 mm
Flavor Imprint Code ML72
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:50268-307-1330 in 1 BOX, UNIT-DOSE
1NDC:50268-307-111 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201022 05/16/2013

PRINCIPAL DISPLAY PANEL

NDC 50268-305-13
Famciclovir Tablets
125 mg
Rx Only
30 Tablets (3 X 10) Unit Dose

5026830513

NDC 50268-305-13
Famciclovir Tablets
125 mg
Rx Only
30 Tablets (3 X 10) Unit Dose

5026830513

Pharmacist: Dispense the Patient Information Leaflet with The Drug Product.

Each film coated tablet contains:
Famciclovir 125 mg

USUAL DOSAGE: See Prescribing Information

Store at 20oC to 25oC (68oF to 77oF) [See USP controlled room temperature].

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

AvPAK
A PRODUCT OF AvKARE

Mfg. PM01265801     AV 05/13 (P)

NDC 50268-306-13
Famciclovir Tablets
250 mg
Rx Only
30 Tablets (3 X 10) Unit Dose

5026830613

NDC 50268-306-13
Famciclovir Tablets
250 mg
Rx Only
30 Tablets (3 X 10) Unit Dose

5026830613

Pharmacist: Dispense the Patient Information Leaflet with The Drug Product.

Each film coated tablet contains:
Famciclovir 250 mg

USUAL DOSAGE: See Prescribing Information

Store at 20oC to 25oC (68oF to 77oF) [See USP controlled room temperature].

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

AvPAK
A PRODUCT OF AvKARE

Mfg. PM01265901     AV 05/13 (P)

NDC 50268-307-13
Famciclovir Tablets
500 mg
Rx Only
30 Tablets (3 X 10) Unit Dose

5026830713

NDC 50268-307-13
Famciclovir Tablets
500 mg
Rx Only
30 Tablets (3 X 10) Unit Dose

5026830713

Pharmacist: Dispense the Patient Information Leaflet with The Drug Product.

Each film coated tablet contains:
Famciclovir 500 mg

USUAL DOSAGE: See Prescribing Information

Store at 20oC to 25oC (68oF to 77oF) [See USP controlled room temperature].

Manufactured for:
AvKARE, Inc.
Pulaski, TN 38478

AvPAK
A PRODUCT OF AvKARE

Mfg. PM01266001     AV 05/13 (P)