XTAMPZA ER (Page 11 of 11)

PRINCIPAL DISPLAY PANEL — 9 mg Capsule Bottle Label

NDC 24510-110-10

Xtampza® ER

(oxycodone)
EXTENDED-RELEASE
CAPSULES
CII

9 mg

Each capsule contains Oxycodone 9 mg
(Equivalent to 10 mg Oxycodone Hydrochloride)

100 Capsules
Rx Only

Always take with food. Taking on an empty
stomach can decrease drug absorption.

Attention Dispenser: Accompanying Medication Guide must be provided to the patient upon dispensing.

PRINCIPAL DISPLAY PANEL -- 9 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 13.5 mg Capsule Bottle Label

NDC 24510-115-10

Xtampza® ER

(oxycodone)
EXTENDED-RELEASE
CAPSULES
CII

13.5 mg

Each capsule contains Oxycodone 13.5 mg
(Equivalent to 15 mg Oxycodone Hydrochloride)

100 Capsules
Rx Only

Always take with food. Taking on an empty
stomach can decrease drug absorption.

Attention Dispenser: Accompanying
Medication Guide must be provided to the patient upon dispensing.

PRINCIPAL DISPLAY PANEL -- 13.5 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 18 mg Capsule Bottle Label

NDC 24510-120-10

Xtampza® ER

(oxycodone)
EXTENDED-RELEASE
CAPSULES
CII

18 mg

Each capsule contains Oxycodone 18 mg
(Equivalent to 20 mg Oxycodone Hydrochloride)

100 Capsules
Rx Only

Always take with food. Taking on an empty
stomach can decrease drug absorption.

Attention Dispenser: Accompanying
Medication Guide must be provided to the patient upon dispensing.

PRINCIPAL DISPLAY PANEL -- 18 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 27 mg Capsule Bottle Label

NDC 24510-130-10

Xtampza® ER

(oxycodone)
EXTENDED-RELEASE
CAPSULES
CII

27 mg

Each capsule contains Oxycodone 27 mg
(Equivalent to 30 mg Oxycodone Hydrochloride)

100 Capsules
Rx Only

Always take with food. Taking on an empty
stomach can decrease drug absorption.

Attention Dispenser: Accompanying
Medication Guide must be provided to the patient upon dispensing.

PRINCIPAL DISPLAY PANEL -- 27 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 36 mg Capsule Bottle Label

NDC 24510-140-10

Xtampza® ER

(oxycodone)
EXTENDED-RELEASE
CAPSULES
CII

36 mg

Each capsule contains Oxycodone 36 mg
(Equivalent to 40 mg Oxycodone Hydrochloride)

100 Capsules
Rx Only

Always take with food. Taking on an empty
stomach can decrease drug absorption.

Attention Dispenser: Accompanying
Medication Guide must be provided to the patient upon dispensing.

PRINCIPAL DISPLAY PANEL -- 36 mg Capsule Bottle Label
(click image for full-size original)
XTAMPZA ER oxycodone capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24510-110
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYCODONE (OXYCODONE) OXYCODONE 9 mg
Inactive Ingredients
Ingredient Name Strength
MYRISTIC ACID
YELLOW WAX
CARNAUBA WAX
PEG-32 STEARATE
MAGNESIUM STEARATE
SILICON DIOXIDE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
WATER
FERRIC OXIDE YELLOW
Product Characteristics
Color WHITE (ivory) Score no score
Shape CAPSULE (Size 3) Size 16mm
Flavor Imprint Code XTAMPZA;ER;9;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24510-110-10 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
2 NDC:24510-110-20 20 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208090 05/10/2016
XTAMPZA ER oxycodone capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24510-115
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYCODONE (OXYCODONE) OXYCODONE 13.5 mg
Inactive Ingredients
Ingredient Name Strength
MYRISTIC ACID
YELLOW WAX
CARNAUBA WAX
PEG-32 STEARATE
MAGNESIUM STEARATE
SILICON DIOXIDE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
WATER
FERRIC OXIDE RED
Product Characteristics
Color ORANGE (swedish orange) , WHITE Score no score
Shape CAPSULE (Size 2) Size 18mm
Flavor Imprint Code XTAMPZA;ER;13;5;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24510-115-10 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
2 NDC:24510-115-20 20 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208090 05/10/2016
XTAMPZA ER oxycodone capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24510-120
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYCODONE (OXYCODONE) OXYCODONE 18 mg
Inactive Ingredients
Ingredient Name Strength
MYRISTIC ACID
YELLOW WAX
CARNAUBA WAX
PEG-32 STEARATE
MAGNESIUM STEARATE
SILICON DIOXIDE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
WATER
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW (rich yellow) , WHITE Score no score
Shape CAPSULE (Size 1) Size 19mm
Flavor Imprint Code XTAMPZA;ER;18;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24510-120-10 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
2 NDC:24510-120-20 20 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208090 05/10/2016
XTAMPZA ER oxycodone capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24510-130
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYCODONE (OXYCODONE) OXYCODONE 27 mg
Inactive Ingredients
Ingredient Name Strength
MYRISTIC ACID
YELLOW WAX
CARNAUBA WAX
PEG-32 STEARATE
MAGNESIUM STEARATE
SILICON DIOXIDE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
WATER
FERROSOFERRIC OXIDE
Product Characteristics
Color GRAY (light gray) , WHITE Score no score
Shape CAPSULE (Size 0) Size 22mm
Flavor Imprint Code XTAMPZA;ER;27;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24510-130-10 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
2 NDC:24510-130-20 20 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208090 05/10/2016
XTAMPZA ER oxycodone capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24510-140
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OXYCODONE (OXYCODONE) OXYCODONE 36 mg
Inactive Ingredients
Ingredient Name Strength
MYRISTIC ACID
YELLOW WAX
CARNAUBA WAX
PEG-32 STEARATE
MAGNESIUM STEARATE
SILICON DIOXIDE
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
WATER
FERRIC OXIDE RED
Product Characteristics
Color PINK (flesh) , WHITE Score no score
Shape CAPSULE (Size 00) Size 23mm
Flavor Imprint Code XTAMPZA;ER;36;mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24510-140-10 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC None
2 NDC:24510-140-20 20 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA208090 05/10/2016
Labeler — Collegium Pharmaceutical, Inc. (032531241)
Establishment
Name Address ID/FEI Operations
Patheon Pharmaceuticals, Inc 005286822 MANUFACTURE (24510-110), MANUFACTURE (24510-115), MANUFACTURE (24510-120), MANUFACTURE (24510-130), MANUFACTURE (24510-140), LABEL (24510-110), LABEL (24510-115), LABEL (24510-120), LABEL (24510-130), LABEL (24510-140), PACK (24510-110), PACK (24510-115), PACK (24510-120), PACK (24510-130), PACK (24510-140)

Revised: 10/2019 Collegium Pharmaceutical, Inc.

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