NDC Code(s) : 69189-5550-1
Packager : Avera McKennan Hospital

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dexmethylphenidate HydrochlorideDexmethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69189-5550(NDC:0093-5550)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXMETHYLPHENIDATE HYDROCHLORIDE(UNII: 1678OK0E08)
(DEXMETHYLPHENIDATE - UNII:M32RH9MFGP) 		DEXMETHYLPHENIDATE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIO METHACRYLATE COPOLYMER TYPE B(UNII: 161H3B14U2)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
ALUMINUM OXIDE(UNII: LMI26O6933)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
INDIGOTINDISULFONATE SODIUM(UNII: D3741U8K7L)
FD&C RED NO. 40(UNII: WZB9127XOA)
GELATIN(UNII: 2G86QN327L)
HYPROMELLOSE 2208 (3 MPA.S)(UNII: 9H4L916OBU)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)(UNII: 74G4R6TH13)
STARCH, CORN(UNII: O8232NY3SJ)
SUCROSE(UNII: C151H8M554)
POLYETHYLENE GLYCOL 6000(UNII: 30IQX730WE)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Product Characteristics
Color BLUE (aqua-blue) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code TEVA;5550
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69189-5550-11 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 ANDA078908 03/06/2015

PRINCIPAL DISPLAY PANEL

Dexmethylphenidate XR 5 mg capsule label