Methylphenidate Hydrochloride: Package Insert and Label Information (Page 6 of 6)

PRINCIPAL DISPLAY PANEL

Methylphenidate Hydrochloride Extended-Release Tablets USP, 18 mg, CII
NDC 62559-790-01
Rx only
100 tablets

Label-18mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

Methylphenidate Hydrochloride Extended-Release Tablets USP, 27 mg, CII
NDC 62559-791-01
Rx only
100 tablets

Label-27mg
(click image for full-size original)

METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62559-790
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
AMMONIA
CETYL ALCOHOL
ETHYLCELLULOSE, UNSPECIFIED
FERROSOFERRIC OXIDE
HYPROMELLOSE 2208 (100000 MPA.S)
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
BUTYL ALCOHOL
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE K30
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
TRIETHYL CITRATE
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW (Yellow) Score no score
Shape CAPSULE (modified capsule-shaped) Size 14mm
Flavor Imprint Code ANI;790
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62559-790-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208607 03/25/2019
METHYLPHENIDATE HYDROCHLORIDE methylphenidate hydrochloride tablet, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62559-791
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
AMMONIA
CETYL ALCOHOL
ETHYLCELLULOSE, UNSPECIFIED
FERROSOFERRIC OXIDE
HYPROMELLOSE 2208 (100000 MPA.S)
HYPROMELLOSE 2910 (3 MPA.S)
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
BUTYL ALCOHOL
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE K30
PROPYLENE GLYCOL
SHELLAC
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
TRIETHYL CITRATE
Product Characteristics
Color GRAY (Gray) Score no score
Shape CAPSULE (modified capsule-shaped) Size 14mm
Flavor Imprint Code ANI;791
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62559-791-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208607 03/25/2019
Labeler — ANI Pharmaceuticals, Inc. (145588013)

Revised: 05/2020 ANI Pharmaceuticals, Inc.

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