NDC Code(s) : 69296-005-01, 69296-006-01, 69296-007-01
Packager : Inspirion Delivery Sciences Llc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

ROXYBONDoxycodone hydrochloride TABLET, COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69296-005
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
Inactive Ingredients
Ingredient Name Strength
ALGINIC ACID(UNII: 8C3Z4148WZ)
AMMONIA(UNII: 5138Q19F1X)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER(UNII: 905HNO1SIH)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)(UNII: P2OM2Q86BI)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SODIUM ALGINATE(UNII: C269C4G2ZQ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
XANTHAN GUM(UNII: TTV12P4NEE)
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 11 mm
Flavor Imprint Code IDT;O5
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69296-005-01100 in 1 BOTTLE Type 0: Not a Combination Product10/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA209777 10/01/2017
ROXYBONDoxycodone hydrochloride TABLET, COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69296-006
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 HYDROCHLORIDE15 mg
Inactive Ingredients
Ingredient Name Strength
ALGINIC ACID(UNII: 8C3Z4148WZ)
AMMONIA(UNII: 5138Q19F1X)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER(UNII: 905HNO1SIH)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)(UNII: P2OM2Q86BI)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SODIUM ALGINATE(UNII: C269C4G2ZQ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
XANTHAN GUM(UNII: TTV12P4NEE)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
Color GREEN Score no score
Shape ROUND Size 11 mm
Flavor Imprint Code IDT;O15
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69296-006-01100 in 1 BOTTLE Type 0: Not a Combination Product10/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA209777 10/01/2017
ROXYBONDoxycodone hydrochloride TABLET, COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69296-007
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
Inactive Ingredients
Ingredient Name Strength
ALGINIC ACID(UNII: 8C3Z4148WZ)
AMMONIA(UNII: 5138Q19F1X)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER(UNII: 905HNO1SIH)
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)(UNII: P2OM2Q86BI)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ISOPROPYL ALCOHOL(UNII: ND2M416302)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MANNITOL(UNII: 3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
BUTYL ALCOHOL(UNII: 8PJ61P6TS3)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
SODIUM ALGINATE(UNII: C269C4G2ZQ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
XANTHAN GUM(UNII: TTV12P4NEE)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 11 mm
Flavor Imprint Code IDT;O30
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69296-007-01100 in 1 BOTTLE Type 0: Not a Combination Product10/01/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA209777 10/01/2017

PRINCIPAL DISPLAY PANEL

Principal Display Panel - 5 mg Bottle LabelBottle Label - 5 mg

NDC 69296-005-01          100 Tablets

RoxyBond™ CII
(oxycodone hydrochloride)
Tablets

5 mg

Rx Only

Manufactured for:
Inspirion Delivery Sciences, LLC by:
Cerovene Inc., NY 10989 USA

(Logo Placement)

Each tablet contains:
Oxycodone Hydrochloride, USP   5 mg*
*5 mg oxycodone HCl is equivalent to
4.5 mg of oxycodone.

See package insert for complete
prescribing information.

Store at 25°C (77°F) excursions are
permitted to 15°-30°C (59°-86°F)
[See USP Controlled Room Temperature]

PROTECT FROM MOISTURE

Dispense in a well-closed container as
defined in the USP/NF, with a child-resistant
closure.

TABLETS IDENTIFIED IDT/O 5

(Side One)        IDT O 5 (Side Two)

DO NOT USE UNLESS TABLETS
CARRY THIS IDENTIFICATION

EXP. LOT

XXXXX-XX
Iss 03/2017

PRINCIPAL DISPLAY PANEL

Principal Display Panel - 15 mg Bottle LabelBottle Label - 15 mg

NDC 69296-006-01          100 Tablets

RoxyBond™ CII
(oxycodone hydrochloride)
Tablets

15 mg

Rx Only

Manufactured for:
Inspirion Delivery Sciences, LLC by:
Cerovene Inc., NY 10989 USA

(Logo Placement)

Each tablet contains:
Oxycodone Hydrochloride, USP   15 mg*
*15 mg oxycodone HCl is equivalent to
13.4 mg of oxycodone.

See package insert for complete
prescribing information.

Store at 25°C (77°F) excursions are
permitted to 15°-30°C (59°-86°F)
[See USP Controlled Room Temperature]

PROTECT FROM MOISTURE

Dispense in a well-closed container as
defined in the USP/NF, with a child-resistant
closure.

TABLETS IDENTIFIED IDT/O 15

(Side One)        IDT O 15 (Side Two)

DO NOT USE UNLESS TABLETS
CARRY THIS IDENTIFICATION

EXP. LOT

XXXXX-XX
Iss 03/2017

PRINCIPAL DISPLAY PANEL

Principal Display Panel - 30 mg Bottle labelBottle Label - 30 mg

NDC 69296-007-01          100 Tablets

RoxyBond™ CII
(oxycodone hydrochloride)
Tablets

30 mg

Rx Only

Manufactured for:
Inspirion Delivery Sciences, LLC by:
Cerovene Inc., NY 10989 USA

(Logo Placement)

Each tablet contains:
Oxycodone Hydrochloride, USP   30 mg*
*30 mg oxycodone HCl is equivalent to
26.9 mg of oxycodone.

See package insert for complete
prescribing information.

Store at 25°C (77°F) excursions are
permitted to 15°-30°C (59°-86°F)
[See USP Controlled Room Temperature]

PROTECT FROM MOISTURE

Dispense in a well-closed container as
defined in the USP/NF, with a child-resistant
closure.

TABLETS IDENTIFIED IDT/O 30

(Side One)        IDT O 30 (Side Two)

DO NOT USE UNLESS TABLETS
CARRY THIS IDENTIFICATION

EXP. LOT

XXXXX-XX
Iss 03/2017