RELEXXII (Page 9 of 9)

PRINCIPAL DISPLAY PANEL

RELEXXII ® 72 mg 30 count Bottle Label

NDC 68025-084-30

RELEXXII 72 mg 30ct BL Rev. 11/2021
(click image for full-size original)
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
2 NDC:68025-084-10 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA205327 11/08/2018
Labeler — Vertical Pharmaceuticals, LLC (173169017)

Revised: 11/2021 Vertical Pharmaceuticals, LLC

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