NDC Code 45963-201-11 - Methylphenidate Hydrochloride

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

Methylphenidate HydrochlorideMethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHYLPHENIDATE HYDROCHLORIDE(UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49)	METHYLPHENIDATE HYDROCHLORIDE	20 mg

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:45963-200-11	100 in 1 BOTTLE Type 0: Not a Combination Product	26/01/2016
2	NDC:45963-200-25	250 in 1 BOTTLE Type 0: Not a Combination Product	26/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078458	01/26/2016	09/28/2017

Methylphenidate HydrochlorideMethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHYLPHENIDATE HYDROCHLORIDE(UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49)	METHYLPHENIDATE HYDROCHLORIDE	30 mg

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:45963-201-11	100 in 1 BOTTLE Type 0: Not a Combination Product	28/12/2015
2	NDC:45963-201-25	250 in 1 BOTTLE Type 0: Not a Combination Product	28/12/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078458	12/28/2015	08/28/2017

Methylphenidate HydrochlorideMethylphenidate Hydrochloride CAPSULE, EXTENDED RELEASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHYLPHENIDATE HYDROCHLORIDE(UNII: 4B3SC438HI) (METHYLPHENIDATE - UNII:207ZZ9QZ49)	METHYLPHENIDATE HYDROCHLORIDE	40 mg

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:45963-202-11	100 in 1 BOTTLE Type 0: Not a Combination Product	28/12/2015
2	NDC:45963-202-25	250 in 1 BOTTLE Type 0: Not a Combination Product	28/12/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA078458	12/28/2015	09/28/2017

NDC 45963-201-11
API & Excipient Details