Nucynta ER (Page 10 of 10)

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NUCYNTA ER
tapentadol hydrochloride tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55700-796(NDC:24510-058)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TAPENTADOL HYDROCHLORIDE (TAPENTADOL) TAPENTADOL 50 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
.ALPHA.-TOCOPHEROL
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
TALC
SHELLAC
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
Product Characteristics
Color WHITE Score no score
Shape OVAL (oblong-shaped) Size 17mm
Flavor Imprint Code OMJ;50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55700-796-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA200533 09/27/2019
NUCYNTA ER
tapentadol hydrochloride tablet, film coated, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55700-797(NDC:24510-116)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TAPENTADOL HYDROCHLORIDE (TAPENTADOL) TAPENTADOL 100 mg
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
.ALPHA.-TOCOPHEROL
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
TALC
SHELLAC
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
FD&C BLUE NO. 2
ALUMINUM OXIDE
Product Characteristics
Color BLUE (light blue) Score no score
Shape OVAL (oblong-shaped) Size 17mm
Flavor Imprint Code OMJ;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55700-797-60 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA200533 09/27/2019
Labeler — Quality Care Products, LLC (831276758)
Establishment
Name Address ID/FEI Operations
Quality Care Products, LLC 831276758 relabel (55700-796), relabel (55700-797)

Revised: 07/2021 Quality Care Products, LLC

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