Nucynta (Page 7 of 7)

PRINCIPAL DISPLAY PANEL

NUCYNTA
(tapentadol) Tablets

50 mg

CII

Each tablet contains:

tapentadol 50 mg

Caution: Federal law prohibits the transfer
of this drug to any person other than the patient
for whom it was prescribed.

Please see the Medication Guide provided by your pharmacist.

image of 50 mg package label
(click image for full-size original)


NUCYNTA
(tapentadol) Tablets

75 mg

CII

Each tablet contains:

tapentadol 75 mg

Caution: Federal law prohibits the transfer
of this drug to any person other than the patientfor whom it was prescribed.

Please see the Medication Guide

image of 75 mg package label
(click image for full-size original)


NUCYNTA
(tapentadol) Tablets

100 mg

CII

Each tablet contains:

tapentadol 100 mg

Caution: Federal law prohibits the transfer
of this drug to any person other than the patient
for whom it was prescribed.

Please see the Medication Guide provided by your pharmacist.

image of 100 mg package label
(click image for full-size original)
NUCYNTA tapentadol hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5979(NDC:50458-820)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TAPENTADOL HYDROCHLORIDE (TAPENTADOL) TAPENTADOL HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
LACTOSE MONOHYDRATE
CROSCARMELLOSE SODIUM
POVIDONE
MAGNESIUM STEARATE
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL
TALC
ALUMINUM OXIDE
Product Characteristics
Color yellow Score no score
Shape ROUND (round and biconvex) Size 7mm
Flavor Imprint Code O;M;50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5979-0 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
2 NDC:54868-5979-1 10 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022304 03/19/2010
NUCYNTA tapentadol hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6002(NDC:50458-830)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TAPENTADOL HYDROCHLORIDE (TAPENTADOL) TAPENTADOL HYDROCHLORIDE 75 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
LACTOSE MONOHYDRATE
CROSCARMELLOSE SODIUM
POVIDONE
MAGNESIUM STEARATE
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL
TALC
ALUMINUM OXIDE
Product Characteristics
Color yellow (yellow orange) Score no score
Shape ROUND (round and bioxonvex) Size 8mm
Flavor Imprint Code O;M;75
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-6002-0 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022304 03/19/2010
NUCYNTA tapentadol hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-6039(NDC:50458-840)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TAPENTADOL HYDROCHLORIDE (TAPENTADOL) TAPENTADOL HYDROCHLORIDE 100 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
LACTOSE MONOHYDRATE
CROSCARMELLOSE SODIUM
POVIDONE
MAGNESIUM STEARATE
POLYVINYL ALCOHOL
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL
TALC
ALUMINUM OXIDE
Product Characteristics
Color orange Score no score
Shape ROUND (round and biconvex) Size 9mm
Flavor Imprint Code O;M;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-6039-0 60 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022304 03/19/2010
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel, repack

Revised: 03/2010 Physicians Total Care, Inc.

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