NDC Code(s) : 0378-7103-01, 0378-7104-01, 0378-7105-01, 0378-7106-01, 0378-7107-01, 0378-7108-01
Packager : Mylan Pharmaceuticals Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Oxycodone and AcetaminophenOxycodone hydrochloride and Acetaminophen TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-7103
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Oxycodone hydrochloride(UNII: C1ENJ2TE6C)
(Oxycodone - UNII:CD35PMG570) 		Oxycodone hydrochloride2.5 mg
Acetaminophen(UNII: 362O9ITL9D)
(Acetaminophen - UNII:362O9ITL9D) 		Acetaminophen325 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide(UNII: ETJ7Z6XBU4)
croscarmellose sodium(UNII: M28OL1HH48)
crospovidone (15 mpa.s at 5%)(UNII: 68401960MK)
cellulose, microcrystalline(UNII: OP1R32D61U)
povidones(UNII: FZ989GH94E)
stearic acid(UNII: 4ELV7Z65AP)
starch, corn(UNII: O8232NY3SJ)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 14 mm
Flavor Imprint Code 103
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-7103-01100 in 1 BOTTLE Type 0: Not a Combination Product16/12/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090177 12/16/2008 07/31/2018
Oxycodone and AcetaminophenOxycodone hydrochloride and Acetaminophen TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-7104
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Oxycodone hydrochloride(UNII: C1ENJ2TE6C)
(Oxycodone - UNII:CD35PMG570) 		Oxycodone hydrochloride5 mg
Acetaminophen(UNII: 362O9ITL9D)
(Acetaminophen - UNII:362O9ITL9D) 		Acetaminophen325 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide(UNII: ETJ7Z6XBU4)
croscarmellose sodium(UNII: M28OL1HH48)
crospovidone (15 mpa.s at 5%)(UNII: 68401960MK)
cellulose, microcrystalline(UNII: OP1R32D61U)
povidones(UNII: FZ989GH94E)
stearic acid(UNII: 4ELV7Z65AP)
starch, corn(UNII: O8232NY3SJ)
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 11 mm
Flavor Imprint Code 104
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-7104-01100 in 1 BOTTLE Type 0: Not a Combination Product16/12/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090177 12/16/2008 12/31/2018
Oxycodone and AcetaminophenOxycodone hydrochloride and Acetaminophen TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-7105
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Oxycodone hydrochloride(UNII: C1ENJ2TE6C)
(Oxycodone - UNII:CD35PMG570) 		Oxycodone hydrochloride7.5 mg
Acetaminophen(UNII: 362O9ITL9D)
(Acetaminophen - UNII:362O9ITL9D) 		Acetaminophen325 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide(UNII: ETJ7Z6XBU4)
croscarmellose sodium(UNII: M28OL1HH48)
crospovidone (15 mpa.s at 5%)(UNII: 68401960MK)
cellulose, microcrystalline(UNII: OP1R32D61U)
povidones(UNII: FZ989GH94E)
stearic acid(UNII: 4ELV7Z65AP)
starch, corn(UNII: O8232NY3SJ)
Product Characteristics
Color WHITE Score no score
Shape OVAL (caplet-shaped) Size 16 mm
Flavor Imprint Code 105
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-7105-01100 in 1 BOTTLE Type 0: Not a Combination Product16/12/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090177 12/16/2008 09/30/2018
Oxycodone and AcetaminophenOxycodone hydrochloride and Acetaminophen TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-7106
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Oxycodone hydrochloride(UNII: C1ENJ2TE6C)
(Oxycodone - UNII:CD35PMG570) 		Oxycodone hydrochloride10 mg
Acetaminophen(UNII: 362O9ITL9D)
(Acetaminophen - UNII:362O9ITL9D) 		Acetaminophen325 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide(UNII: ETJ7Z6XBU4)
croscarmellose sodium(UNII: M28OL1HH48)
crospovidone (15 mpa.s at 5%)(UNII: 68401960MK)
cellulose, microcrystalline(UNII: OP1R32D61U)
povidones(UNII: FZ989GH94E)
stearic acid(UNII: 4ELV7Z65AP)
starch, corn(UNII: O8232NY3SJ)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 13 mm
Flavor Imprint Code 106
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-7106-01100 in 1 BOTTLE Type 0: Not a Combination Product16/12/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090177 12/16/2008 03/31/2018
Oxycodone and AcetaminophenOxycodone hydrochloride and Acetaminophen TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-7107
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Oxycodone hydrochloride(UNII: C1ENJ2TE6C)
(Oxycodone - UNII:CD35PMG570) 		Oxycodone hydrochloride7.5 mg
Acetaminophen(UNII: 362O9ITL9D)
(Acetaminophen - UNII:362O9ITL9D) 		Acetaminophen500 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide(UNII: ETJ7Z6XBU4)
croscarmellose sodium(UNII: M28OL1HH48)
crospovidone (15 mpa.s at 5%)(UNII: 68401960MK)
cellulose, microcrystalline(UNII: OP1R32D61U)
povidones(UNII: FZ989GH94E)
stearic acid(UNII: 4ELV7Z65AP)
starch, corn(UNII: O8232NY3SJ)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 17 mm
Flavor Imprint Code 107
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-7107-01100 in 1 BOTTLE Type 0: Not a Combination Product16/12/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090177 12/16/2008 01/31/2015
Oxycodone and AcetaminophenOxycodone hydrochloride and Acetaminophen TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0378-7108
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Oxycodone hydrochloride(UNII: C1ENJ2TE6C)
(Oxycodone - UNII:CD35PMG570) 		Oxycodone hydrochloride10 mg
Acetaminophen(UNII: 362O9ITL9D)
(Acetaminophen - UNII:362O9ITL9D) 		Acetaminophen650 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide(UNII: ETJ7Z6XBU4)
croscarmellose sodium(UNII: M28OL1HH48)
crospovidone (15 mpa.s at 5%)(UNII: 68401960MK)
cellulose, microcrystalline(UNII: OP1R32D61U)
povidones(UNII: FZ989GH94E)
stearic acid(UNII: 4ELV7Z65AP)
starch, corn(UNII: O8232NY3SJ)
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 18 mm
Flavor Imprint Code 108
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0378-7108-01100 in 1 BOTTLE Type 0: Not a Combination Product16/12/2008
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090177 12/16/2008 01/31/2015

PRINCIPAL DISPLAY PANEL

MYLAN®

NDC 0378-7103-01

CII

OXYCODONE and
ACETAMINOPHEN
TABLETS, USP

2.5 mg*/325 mg

Multiple strengths: Do not dispense
unless strength is stated

100 TABLETS

Rx only

PRINCIPAL DISPLAY PANEL - 2.5 mg/325 mg Bottle Label

PRINCIPAL DISPLAY PANEL

MYLAN®

NDC 0378-7104-01

CII

OXYCODONE and
ACETAMINOPHEN
TABLETS, USP

5 mg*/325 mg

Multiple strengths: Do not dispense
unless strength is stated

100 TABLETS

Rx only

PRINCIPAL DISPLAY PANEL - 5 mg/325 mg Bottle Label

PRINCIPAL DISPLAY PANEL

MYLAN®

NDC 0378-7105-01

CII

OXYCODONE and
ACETAMINOPHEN
TABLETS, USP

7.5 mg*/325 mg

Multiple strengths: Do not dispense
unless strength is stated

100 TABLETS

Rx only

PRINCIPAL DISPLAY PANEL - 7.5 mg/325 mg Bottle Label

PRINCIPAL DISPLAY PANEL

MYLAN®

NDC 0378-7106-01

CII

OXYCODONE and
ACETAMINOPHEN
TABLETS, USP

10 mg*/325 mg

Multiple strengths: Do not dispense
unless strength is stated

100 TABLETS

Rx only

PRINCIPAL DISPLAY PANEL - 10 mg/325 mg Bottle Label

PRINCIPAL DISPLAY PANEL

MYLAN®

NDC 0378-7107-01

CII

OXYCODONE and
ACETAMINOPHEN
TABLETS, USP

7.5 mg*/500 mg

Multiple strengths: Do not dispense
unless strength is stated

100 TABLETS

Rx only

PRINCIPAL DISPLAY PANEL - 7.5 mg/500 mg Bottle Label

PRINCIPAL DISPLAY PANEL

MYLAN®

NDC 0378-7108-01

CII

OXYCODONE and
ACETAMINOPHEN
TABLETS, USP

10 mg*/650 mg

Multiple strengths: Do not dispense
unless strength is stated

100 TABLETS

Rx only

PRINCIPAL DISPLAY PANEL - 10 mg/650 mg Bottle Label