RELEXXII (Page 9 of 9)

PRINCIPAL DISPLAY PANEL

RELEXXII® 18 mg 100 count Bottle Label

NDC 68025-095-10

RELEXXII 18 mg 100ct BL
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

RELEXXII® 27 mg 100 count Bottle Label

NDC 68025-096-10

RELEXXII 27 mg 100ct BL
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

RELEXXII® 36 mg 100 count Bottle Label

NDC 68025-097-10

RELEXXII 36 mg 100ct BL
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

RELEXXII® 45 mg 30 count Bottle Label

NDC 68025-088-30

RELEXXII 45 mg 30ct Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

RELEXXII® 54 mg 100 count Bottle Label

NDC 68025-098-10

RELEXXII 54 mg 100ct BL
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

RELEXXII® 63 mg 30 count Bottle Label

NDC 68025-089-30

RELEXXII 63 mg 30ct Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

RELEXXII® 72 mg 30 count Bottle Label

NDC 68025-084-30

RELEXXII 72 mg 30ct BL
(click image for full-size original)
RELEXXII methylphenidate hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68025-088
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE) METHYLPHENIDATE HYDROCHLORIDE 45 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
PHOSPHORIC ACID
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
SODIUM CHLORIDE
MAGNESIUM STEARATE
SUCCINIC ACID
FERROSOFERRIC OXIDE
TITANIUM DIOXIDE
FD&C RED NO. 40
CELLULOSE ACETATE
LACTOSE MONOHYDRATE
POLYETHYLENE OXIDE 200000
POLYETHYLENE OXIDE 5000000
TRIACETIN
Product Characteristics
Color pink Score no score
Shape ROUND Size 10mm
Flavor Imprint Code TL711
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68025-088-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA216117 06/23/2022
RELEXXII methylphenidate hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68025-089
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE) METHYLPHENIDATE HYDROCHLORIDE 63 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE ACETATE
SILICON DIOXIDE
FERROSOFERRIC OXIDE
HYPROMELLOSES
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
PHOSPHORIC ACID
SODIUM CHLORIDE
SUCCINIC ACID
TITANIUM DIOXIDE
TRIACETIN
POLYETHYLENE GLYCOL, UNSPECIFIED
POLYETHYLENE OXIDE 200000
POLYETHYLENE OXIDE 5000000
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color orange Score no score
Shape ROUND Size 10mm
Flavor Imprint Code TL700
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68025-089-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA216117 06/23/2022
RELEXXII methylphenidate hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68025-095
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
CELLULOSE ACETATE
SILICON DIOXIDE
FERROSOFERRIC OXIDE
HYPROMELLOSES
PHOSPHORIC ACID
POLYETHYLENE GLYCOL, UNSPECIFIED
SODIUM CHLORIDE
MAGNESIUM STEARATE
SUCCINIC ACID
TITANIUM DIOXIDE
TRIACETIN
LACTOSE MONOHYDRATE
POLYETHYLENE OXIDE 200000
POLYETHYLENE OXIDE 5000000
Product Characteristics
Color yellow Score no score
Shape ROUND Size 6mm
Flavor Imprint Code TL706
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68025-095-10 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA216117 06/23/2022
RELEXXII methylphenidate hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68025-096
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
HYPROMELLOSES
PHOSPHORIC ACID
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
MAGNESIUM STEARATE
SUCCINIC ACID
FERROSOFERRIC OXIDE
TITANIUM DIOXIDE
TRIACETIN
CELLULOSE ACETATE
LACTOSE MONOHYDRATE
FD&C BLUE NO. 2
FD&C YELLOW NO. 6
FD&C RED NO. 40
POLYETHYLENE OXIDE 200000
POLYETHYLENE OXIDE 5000000
Product Characteristics
Color gray Score no score
Shape ROUND Size 7mm
Flavor Imprint Code TL707
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68025-096-10 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA216117 06/23/2022
RELEXXII methylphenidate hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68025-097
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
HYPROMELLOSES
PHOSPHORIC ACID
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
SODIUM CHLORIDE
MAGNESIUM STEARATE
SUCCINIC ACID
FERROSOFERRIC OXIDE
TITANIUM DIOXIDE
TRIACETIN
CELLULOSE ACETATE
LACTOSE MONOHYDRATE
POLYETHYLENE OXIDE 200000
POLYETHYLENE OXIDE 5000000
Product Characteristics
Color white Score no score
Shape ROUND Size 8mm
Flavor Imprint Code TL708
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68025-097-10 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA216117 06/23/2022
RELEXXII methylphenidate hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68025-084
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE) METHYLPHENIDATE HYDROCHLORIDE 72 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
PHOSPHORIC ACID
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
SODIUM CHLORIDE
FERROSOFERRIC OXIDE
CELLULOSE ACETATE
FD&C BLUE NO. 1
POLYETHYLENE OXIDE 200000
SUCCINIC ACID
MAGNESIUM STEARATE
LACTOSE MONOHYDRATE
TITANIUM DIOXIDE
TRIACETIN
POLYETHYLENE OXIDE 5000000
Product Characteristics
Color blue Score no score
Shape ROUND Size 10mm
Flavor Imprint Code TL710
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68025-084-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA216117 06/23/2022
RELEXXII methylphenidate hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68025-098
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
HYPROMELLOSES
PHOSPHORIC ACID
POLYETHYLENE GLYCOL, UNSPECIFIED
SILICON DIOXIDE
SODIUM CHLORIDE
MAGNESIUM STEARATE
SUCCINIC ACID
FERROSOFERRIC OXIDE
CELLULOSE ACETATE
POLYETHYLENE OXIDE 200000
FD&C RED NO. 40
FD&C BLUE NO. 2
LACTOSE MONOHYDRATE
TITANIUM DIOXIDE
TRIACETIN
FD&C YELLOW NO. 6
POLYETHYLENE OXIDE 5000000
Product Characteristics
Color pink Score no score
Shape ROUND Size 8mm
Flavor Imprint Code TL709
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68025-098-10 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA216117 06/23/2022
Labeler — Vertical Pharmaceuticals, LLC (173169017)

Revised: 10/2023 Vertical Pharmaceuticals, LLC

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