NDC Code(s) : 69189-0310-1
Packager : Avera McKennan Hospital

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Methylphenidate HydrochlorideMethylphenidate Hydrochloride TABLET, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69189-0310(NDC:62175-310)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPHENIDATE HYDROCHLORIDE(UNII: 4B3SC438HI)
(METHYLPHENIDATE - UNII:207ZZ9QZ49) 		METHYLPHENIDATE HYDROCHLORIDE18 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 400 MPA.S AT 1%)(UNII: FC40A8XAJ3)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
ETHYLCELLULOSE (10 MPA.S)(UNII: 3DYK7UYZ62)
HYDROXYPROPYL CELLULOSE (TYPE H)(UNII: RFW2ET671P)
HYPROMELLOSES(UNII: 3NXW29V3WO)
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)(UNII: 6N003M473W)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 3350(UNII: G2M7P15E5P)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
FERRIC OXIDE RED(UNII: 1K09F3G675)
Product Characteristics
Color PINK Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code 18
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69189-0310-11 in 1 DOSE PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091695 03/06/2015

PRINCIPAL DISPLAY PANEL

Methylphenidate ER 18 mg tablet label