NDC Code(s) : 0115-1709-01, 0115-1710-01
Packager : Amneal Pharmaceuticals of New York LLC

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:0115-1709
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 HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient Name Strength
ACETYLTRIBUTYL CITRATE(UNII: 0ZBX0N59RZ)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
HYPROMELLOSES(UNII: 3NXW29V3WO)
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)(UNII: 6N003M473W)
SUCROSE(UNII: C151H8M554)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
GELATIN(UNII: 2G86QN327L)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
SHELLAC(UNII: 46N107B71O)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
Product Characteristics
Color white (natural) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code IX;709
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0115-1709-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product07/05/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203614 07/05/2017
Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0115-1710
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 HYDROCHLORIDE35 mg
Inactive Ingredients
Ingredient Name Strength
ACETYLTRIBUTYL CITRATE(UNII: 0ZBX0N59RZ)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
HYPROMELLOSES(UNII: 3NXW29V3WO)
HYPROMELLOSE ACETATE SUCCINATE 06081224 (3 MM2/S)(UNII: 6N003M473W)
SUCROSE(UNII: C151H8M554)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
GELATIN(UNII: 2G86QN327L)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
SHELLAC(UNII: 46N107B71O)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Product Characteristics
Color blue (light blue), white Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code IX;710
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0115-1710-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product07/05/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203614 07/05/2017

LABELER - Amneal Pharmaceuticals of New York LLC(123797875)

PRINCIPAL DISPLAY PANEL

NDC 0115-1709-01

Dexmethylphenidate HCl ER Capsules, 25 mg (CII)

Rx only
100

25 mg label

PRINCIPAL DISPLAY PANEL

NDC 0115-1710-01

Dexmethylphenidate HCl ER Capsules, 35 mg (CII)

Rx only
100 Capsules

35 mg label