NDC Code(s) : 60793-537-01, 60793-531-01, 60793-535-01, 60793-532-01, 60793-533-01, 60793-536-01
Packager : Pfizer Laboratories Div Pfizer Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Troxyca ERoxycodone hydrochloride and naltrexone hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60793-537
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
NALTREXONE HYDROCHLORIDE(UNII: Z6375YW9SF)
(NALTREXONE - UNII:5S6W795CQM) 		NALTREXONE HYDROCHLORIDE1.2 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIO METHACRYLATE COPOLYMER TYPE B(UNII: 161H3B14U2)
SUCROSE(UNII: C151H8M554)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
HYDROXYPROPYL CELLULOSE (1200000 MW)(UNII: RFW2ET671P)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
DIETHYL PHTHALATE(UNII: UF064M00AF)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
TALC(UNII: 7SEV7J4R1U)
Product Characteristics
Color GRAY (silver), YELLOW Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code NTO;10
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60793-537-01100 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207621 08/19/2016
Troxyca ERoxycodone hydrochloride and naltrexone hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60793-531
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 HYDROCHLORIDE20 mg
NALTREXONE HYDROCHLORIDE(UNII: Z6375YW9SF)
(NALTREXONE - UNII:5S6W795CQM) 		NALTREXONE HYDROCHLORIDE2.4 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIO METHACRYLATE COPOLYMER TYPE B(UNII: 161H3B14U2)
SUCROSE(UNII: C151H8M554)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
HYDROXYPROPYL CELLULOSE (1200000 MW)(UNII: RFW2ET671P)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
DIETHYL PHTHALATE(UNII: UF064M00AF)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
TALC(UNII: 7SEV7J4R1U)
FD&C RED NO. 4(UNII: X3W0AM1JLX)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Product Characteristics
Color GRAY (silver), PURPLE (violet) Score no score
Shape CAPSULE Size 16 mm
Flavor Imprint Code NTO;20
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60793-531-01100 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207621 08/19/2016
Troxyca ERoxycodone hydrochloride and naltrexone hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60793-535
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 HYDROCHLORIDE30 mg
NALTREXONE HYDROCHLORIDE(UNII: Z6375YW9SF)
(NALTREXONE - UNII:5S6W795CQM) 		NALTREXONE HYDROCHLORIDE3.6 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIO METHACRYLATE COPOLYMER TYPE B(UNII: 161H3B14U2)
SUCROSE(UNII: C151H8M554)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
HYDROXYPROPYL CELLULOSE (1200000 MW)(UNII: RFW2ET671P)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
DIETHYL PHTHALATE(UNII: UF064M00AF)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
TALC(UNII: 7SEV7J4R1U)
FD&C RED NO. 4(UNII: X3W0AM1JLX)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Product Characteristics
Color GRAY (silver), PURPLE (fuchsia) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code NTO;30
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60793-535-01100 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207621 08/19/2016
Troxyca ERoxycodone hydrochloride and naltrexone hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60793-532
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 HYDROCHLORIDE40 mg
NALTREXONE HYDROCHLORIDE(UNII: Z6375YW9SF)
(NALTREXONE - UNII:5S6W795CQM) 		NALTREXONE HYDROCHLORIDE4.8 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIO METHACRYLATE COPOLYMER TYPE B(UNII: 161H3B14U2)
SUCROSE(UNII: C151H8M554)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
HYDROXYPROPYL CELLULOSE (1200000 MW)(UNII: RFW2ET671P)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
DIETHYL PHTHALATE(UNII: UF064M00AF)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
TALC(UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
Product Characteristics
Color GRAY (silver), GREEN (olive green) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code NTO;40
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60793-532-01100 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207621 08/19/2016
Troxyca ERoxycodone hydrochloride and naltrexone hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60793-533
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 HYDROCHLORIDE60 mg
NALTREXONE HYDROCHLORIDE(UNII: Z6375YW9SF)
(NALTREXONE - UNII:5S6W795CQM) 		NALTREXONE HYDROCHLORIDE7.2 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIO METHACRYLATE COPOLYMER TYPE B(UNII: 161H3B14U2)
SUCROSE(UNII: C151H8M554)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
HYDROXYPROPYL CELLULOSE (1200000 MW)(UNII: RFW2ET671P)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
DIETHYL PHTHALATE(UNII: UF064M00AF)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
TALC(UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C YELLOW NO. 5(UNII: I753WB2F1M)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
Product Characteristics
Color GRAY (silver), GREEN Score no score
Shape CAPSULE Size 22 mm
Flavor Imprint Code NTO;60
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60793-533-01100 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207621 08/19/2016
Troxyca ERoxycodone hydrochloride and naltrexone hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60793-536
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 HYDROCHLORIDE80 mg
NALTREXONE HYDROCHLORIDE(UNII: Z6375YW9SF)
(NALTREXONE - UNII:5S6W795CQM) 		NALTREXONE HYDROCHLORIDE9.6 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIO METHACRYLATE COPOLYMER TYPE B(UNII: 161H3B14U2)
SUCROSE(UNII: C151H8M554)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
HYDROXYPROPYL CELLULOSE (1200000 MW)(UNII: RFW2ET671P)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
DIETHYL PHTHALATE(UNII: UF064M00AF)
MAGNESIUM STEARATE(UNII: 70097M6I30)
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A(UNII: NX76LV5T8J)
ASCORBIC ACID(UNII: PQ6CK8PD0R)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
TALC(UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 4(UNII: X3W0AM1JLX)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
Product Characteristics
Color GRAY (silver), RED (brick red) Score no score
Shape CAPSULE Size 23 mm
Flavor Imprint Code NTO;80
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:60793-536-01100 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA207621 08/19/2016

PRINCIPAL DISPLAY PANEL

ALWAYS DISPENSE WITH MEDICATION GUIDE

NDC 60793-537-01

Pfizer

TROXYCA® ER
(oxycodone hydrochloride
and naltrexone hydrochloride)
extended-release capsules

CII

10 mg/1.2 mg

THE PELLETS SHOULD NOT BE CHEWED, CRUSHED, OR DISSOLVED.

100 Capsules
Rx only

PRINCIPAL DISPLAY PANEL - 10 mg/1.2 mg Capsule Bottle Label

PRINCIPAL DISPLAY PANEL

ALWAYS DISPENSE WITH MEDICATION GUIDE

NDC 60793-531-01

Pfizer

TROXYCA® ER
(oxycodone hydrochloride
and naltrexone hydrochloride)
extended-release capsules

CII

20 mg/2.4 mg

THE PELLETS SHOULD NOT BE CHEWED, CRUSHED, OR DISSOLVED.

100 Capsules
Rx only

PRINCIPAL DISPLAY PANEL - 20 mg/2.4 mg Capsule Bottle Label

PRINCIPAL DISPLAY PANEL

ALWAYS DISPENSE WITH MEDICATION GUIDE

NDC 60793-535-01

Pfizer

TROXYCA® ER
(oxycodone hydrochloride and
naltrexone hydrochloride)
extended-release capsules

CII

30 mg/3.6 mg

THE PELLETS SHOULD NOT BE CHEWED, CRUSHED, OR DISSOLVED.

100 Capsules
Rx only

PRINCIPAL DISPLAY PANEL - 30 mg/3.6 mg Capsule Bottle Label

PRINCIPAL DISPLAY PANEL

ALWAYS DISPENSE WITH MEDICATION GUIDE

NDC 60793-532-01

Pfizer

TROXYCA® ER
(oxycodone hydrochloride and
naltrexone hydrochloride)
extended-release capsules

CII

40 mg/4.8 mg

THE PELLETS SHOULD NOT BE CHEWED, CRUSHED, OR DISSOLVED.

100 Capsules
Rx only

PRINCIPAL DISPLAY PANEL - 40 mg/4.8 mg Capsule Bottle Label

PRINCIPAL DISPLAY PANEL

ALWAYS DISPENSE WITH MEDICATION GUIDE

NDC 60793-533-01

Pfizer

TROXYCA® ER
(oxycodone hydrochloride
and naltrexone hydrochloride)
extended-release capsules

CII

60 mg/7.2 mg

THE PELLETS SHOULD NOT BE CHEWED, CRUSHED, OR DISSOLVED.

For use in opioid-tolerant patients only

100 Capsules
Rx only

PRINCIPAL DISPLAY PANEL - 60 mg/7.2 mg Capsule Bottle Label

PRINCIPAL DISPLAY PANEL

ALWAYS DISPENSE WITH MEDICATION GUIDE

NDC 60793-536-01

Pfizer

TROXYCA® ER
(oxycodone hydrochloride
and naltrexone hydrochloride)
extended-release capsules

CII

80 mg/9.6 mg

THE PELLETS SHOULD NOT BE CHEWED, CRUSHED, OR DISSOLVED.

For use in opioid-tolerant patients only

100 Capsules
Rx only

PRINCIPAL DISPLAY PANEL - 80 mg/9.6 mg Capsule Bottle Label