CONCERTA (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — 18 mg Tablet Bottle Label

NDC 50458-585-01

CONCERTA ®
(methylphenidate HCl)
CII

Extended-release tablets

18 mg

Each tablet contains 18 mg
methylphenidate hydrochloride
in a controlled-release formulation.

Please see the Medication Guide
provided by your pharmacist.

Rx only 100 Tablets

janssen

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

PRINCIPAL DISPLAY PANEL — 27 mg Tablet Bottle Label

NDC 50458-588-01

CONCERTA ®
(methylphenidate HCl)
CII

Extended-release tablets

27 mg

Each tablet contains 27 mg
methylphenidate hydrochloride
in a controlled-release formulation.

Please see the Medication Guide
provided by your pharmacist.

Rx only 100 Tablets

janssen

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

PRINCIPAL DISPLAY PANEL — 36 mg Tablet Bottle Label

NDC 50458-586-01

CONCERTA ®
(methylphenidate HCl)
CII

Extended-release tablets

36 mg

Each tablet contains 36 mg
methylphenidate hydrochloride
in a controlled-release formulation.

Please see the Medication Guide
provided by your pharmacist.

Rx only 100 Tablets

janssen

PRINCIPAL DISPLAY PANEL -- 36 mg Tablet Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 54 mg Tablet Bottle Label

NDC 50458-587-01

CONCERTA ®
(methylphenidate HCl)
CII

Extended-release tablets

54 mg

Each tablet contains 54 mg
methylphenidate hydrochloride
in a controlled-release formulation.

Please see the Medication Guide
provided by your pharmacist.

Rx only 100 Tablets

janssen

PRINCIPAL DISPLAY PANEL -- 54 mg Tablet Bottle Label
(click image for full-size original)
CONCERTA methylphenidate hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50458-585
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE) METHYLPHENIDATE HYDROCHLORIDE 18 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
CARNAUBA WAX
HYPROMELLOSE, UNSPECIFIED
LACTOSE, UNSPECIFIED FORM
PHOSPHORIC ACID
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SODIUM CHLORIDE
STEARIC ACID
SUCCINIC ACID
FERROSOFERRIC OXIDE
TITANIUM DIOXIDE
TRIACETIN
CELLULOSE ACETATE
Product Characteristics
Color yellow (Yellow) Score no score
Shape OVAL (capsule-shaped) Size 12mm
Flavor Imprint Code alza;18
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50458-585-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021121 08/01/2000
CONCERTA methylphenidate hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50458-588
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE) METHYLPHENIDATE HYDROCHLORIDE 27 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
CARNAUBA WAX
HYPROMELLOSE, UNSPECIFIED
LACTOSE, UNSPECIFIED FORM
PHOSPHORIC ACID
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SODIUM CHLORIDE
STEARIC ACID
SUCCINIC ACID
FERROSOFERRIC OXIDE
TITANIUM DIOXIDE
TRIACETIN
CELLULOSE ACETATE
Product Characteristics
Color gray (Gray) Score no score
Shape OVAL (capsule-shaped) Size 12mm
Flavor Imprint Code alza;27
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50458-588-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021121 08/01/2000
CONCERTA methylphenidate hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50458-586
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE) METHYLPHENIDATE HYDROCHLORIDE 36 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
CARNAUBA WAX
HYPROMELLOSE, UNSPECIFIED
LACTOSE, UNSPECIFIED FORM
PHOSPHORIC ACID
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SODIUM CHLORIDE
STEARIC ACID
SUCCINIC ACID
FERROSOFERRIC OXIDE
TITANIUM DIOXIDE
TRIACETIN
CELLULOSE ACETATE
Product Characteristics
Color white (White) Score no score
Shape OVAL (capsule-shaped) Size 15mm
Flavor Imprint Code alza;36
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50458-586-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021121 08/01/2000
CONCERTA methylphenidate hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50458-587
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE) METHYLPHENIDATE HYDROCHLORIDE 54 mg
Inactive Ingredients
Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
CARNAUBA WAX
HYPROMELLOSE, UNSPECIFIED
LACTOSE, UNSPECIFIED FORM
PHOSPHORIC ACID
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE, UNSPECIFIED
PROPYLENE GLYCOL
SODIUM CHLORIDE
STEARIC ACID
SUCCINIC ACID
FERROSOFERRIC OXIDE
TITANIUM DIOXIDE
TRIACETIN
CELLULOSE ACETATE
Product Characteristics
Color red (Red) Score no score
Shape OVAL (capsule-shaped) Size 15mm
Flavor Imprint Code alza;54
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50458-587-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021121 08/01/2000
Labeler — Janssen Pharmaceuticals, Inc. (063137772)
Establishment
Name Address ID/FEI Operations
Janssen Pharmaceutica Inc 063137772 analysis (50458-585), analysis (50458-588), analysis (50458-586), analysis (50458-587)
Establishment
Name Address ID/FEI Operations
Janssen Pharmaceutica Inc 868441320 analysis (50458-585), analysis (50458-588), analysis (50458-586), analysis (50458-587)
Establishment
Name Address ID/FEI Operations
Janssen-Cilag Manufacturing, LLC 963971374 analysis (50458-585), analysis (50458-588), analysis (50458-586), analysis (50458-587), manufacture (50458-585), manufacture (50458-588), manufacture (50458-586), manufacture (50458-587)
Establishment
Name Address ID/FEI Operations
AndersonBrecon Inc. 053217022 pack (50458-585), pack (50458-588), pack (50458-586), pack (50458-587)
Establishment
Name Address ID/FEI Operations
Janssen Ortho, LLC 805887986 pack (50458-585), pack (50458-588), pack (50458-586), pack (50458-587), analysis (50458-585), analysis (50458-588), analysis (50458-586), analysis (50458-587)
Establishment
Name Address ID/FEI Operations
Janssen Pharmaceutica Inc. 080236951 api manufacture (50458-585), api manufacture (50458-588), api manufacture (50458-586), api manufacture (50458-587)

Revised: 10/2023 Janssen Pharmaceuticals, Inc.

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