NDC Code(s) : 45963-200-11, 45963-200-25, 45963-201-11, 45963-201-25, 45963-202-11, 45963-202-25
Packager : Actavis Pharma, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Methylphenidate HydrochlorideMethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45963-200
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 HYDROCHLORIDE20 mg
Inactive Ingredients
Ingredient Name Strength
SUCROSE(UNII: C151H8M554)
STARCH, CORN(UNII: O8232NY3SJ)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
CELLULOSE ACETATE(UNII: 3J2P07GVB6)
HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S)(UNII: 36BGF0E889)
ACETYLTRIBUTYL CITRATE(UNII: 0ZBX0N59RZ)
ACETONE(UNII: 1364PS73AF)
TALC(UNII: 7SEV7J4R1U)
WATER(UNII: 059QF0KO0R)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
SHELLAC(UNII: 46N107B71O)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
Product Characteristics
Color WHITE, WHITE Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code 200
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:45963-200-11100 in 1 BOTTLE Type 0: Not a Combination Product26/01/2016
2NDC:45963-200-25250 in 1 BOTTLE Type 0: Not a Combination Product26/01/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078458 01/26/2016 09/28/2017
Methylphenidate HydrochlorideMethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45963-201
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 HYDROCHLORIDE30 mg
Inactive Ingredients
Ingredient Name Strength
SUCROSE(UNII: C151H8M554)
STARCH, CORN(UNII: O8232NY3SJ)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
CELLULOSE ACETATE(UNII: 3J2P07GVB6)
HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S)(UNII: 36BGF0E889)
ACETYLTRIBUTYL CITRATE(UNII: 0ZBX0N59RZ)
ACETONE(UNII: 1364PS73AF)
TALC(UNII: 7SEV7J4R1U)
WATER(UNII: 059QF0KO0R)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
SHELLAC(UNII: 46N107B71O)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
D&C RED NO. 28(UNII: 767IP0Y5NH)
Product Characteristics
Color WHITE, BLUE (light blue) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code 201
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:45963-201-11100 in 1 BOTTLE Type 0: Not a Combination Product28/12/2015
2NDC:45963-201-25250 in 1 BOTTLE Type 0: Not a Combination Product28/12/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078458 12/28/2015 08/28/2017
Methylphenidate HydrochlorideMethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:45963-202
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 HYDROCHLORIDE40 mg
Inactive Ingredients
Ingredient Name Strength
SUCROSE(UNII: C151H8M554)
STARCH, CORN(UNII: O8232NY3SJ)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
CELLULOSE ACETATE(UNII: 3J2P07GVB6)
HYPROMELLOSE ACETATE SUCCINATE 12070923 (3 MM2/S)(UNII: 36BGF0E889)
ACETYLTRIBUTYL CITRATE(UNII: 0ZBX0N59RZ)
ACETONE(UNII: 1364PS73AF)
TALC(UNII: 7SEV7J4R1U)
WATER(UNII: 059QF0KO0R)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
SHELLAC(UNII: 46N107B71O)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
D&C RED NO. 28(UNII: 767IP0Y5NH)
Product Characteristics
Color WHITE, BLUE (dark blue) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code 202
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:45963-202-11100 in 1 BOTTLE Type 0: Not a Combination Product28/12/2015
2NDC:45963-202-25250 in 1 BOTTLE Type 0: Not a Combination Product28/12/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078458 12/28/2015 09/28/2017

PRINCIPAL DISPLAY PANEL

Methylphenidate Hydrochloride Extended-Release Capsules (LA) CII 20 mg, 100s Label

PRINCIPAL DISPLAY PANEL

Methylphenidate Hydrochloride Extended-Release Capsules (LA) CII 30 mg, 100s Label

PRINCIPAL DISPLAY PANEL

Methylphenidate Hydrochloride Extended-Release Capsules (LA) CII 40 mg, 100s Label