NDC Code(s) : 57664-376-83, 57664-376-88, 57664-376-08, 57664-376-13, 57664-376-18, 57664-378-83, 57664-378-88, 57664-378-08, 57664-378-13, 57664-378-18, 57664-379-83, 57664-379-88, 57664-379-08, 57664-379-13, 57664-379-18
Packager : Sun Pharmaceutical Industries, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57664-376
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 HYDROCHLORIDE2.5 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TALC(UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Product Characteristics
Color blue (Light Blue) Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code 376;S2;5
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57664-376-8330 in 1 BOTTLE Type 0: Not a Combination Product26/09/2013
2NDC:57664-376-88100 in 1 BOTTLE Type 0: Not a Combination Product26/09/2013
3NDC:57664-376-08100 in 1 BOTTLE Type 0: Not a Combination Product26/09/2013
4NDC:57664-376-13500 in 1 BOTTLE Type 0: Not a Combination Product26/09/2013
5NDC:57664-376-181000 in 1 BOTTLE Type 0: Not a Combination Product26/09/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201231 09/26/2013
Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57664-378
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
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TALC(UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
Product Characteristics
Color yellow (Light Yellow) Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code 378;S5
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57664-378-8330 in 1 BOTTLE Type 0: Not a Combination Product26/09/2013
2NDC:57664-378-88100 in 1 BOTTLE Type 0: Not a Combination Product26/09/2013
3NDC:57664-378-08100 in 1 BOTTLE Type 0: Not a Combination Product26/09/2013
4NDC:57664-378-13500 in 1 BOTTLE Type 0: Not a Combination Product26/09/2013
5NDC:57664-378-181000 in 1 BOTTLE Type 0: Not a Combination Product26/09/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201231 09/26/2013
Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57664-379
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 HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TALC(UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE(UNII: 70097M6I30)
Product Characteristics
Color white Score no score
Shape ROUND Size 6 mm
Flavor Imprint Code 379;S10
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:57664-379-8330 in 1 BOTTLE Type 0: Not a Combination Product26/09/2013
2NDC:57664-379-88100 in 1 BOTTLE Type 0: Not a Combination Product26/09/2013
3NDC:57664-379-08100 in 1 BOTTLE Type 0: Not a Combination Product26/09/2013
4NDC:57664-379-13500 in 1 BOTTLE Type 0: Not a Combination Product26/09/2013
5NDC:57664-379-181000 in 1 BOTTLE Type 0: Not a Combination Product26/09/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201231 09/26/2013

LABELER - Sun Pharmaceutical Industries, Inc.(146974886)

Establishment
Name Address ID/FEI Business Operations
Ohm Laboratories Inc. 184769029 manufacture(57664-376, 57664-378, 57664-379)

PRINCIPAL DISPLAY PANEL

DMPD-2.5mg

PRINCIPAL DISPLAY PANEL

DMPD-5mg

PRINCIPAL DISPLAY PANEL

DMPD-10mg