NDC Code(s) : 0115-9922-01, 0115-9920-01, 0115-9919-01, 0115-9918-01, 0115-9921-01
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:0115-9922
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 HYDROCHLORIDE30 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)
Product Characteristics
Color white Score no score
Shape CAPSULE Size 23 mm
Flavor Imprint Code IX;686
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0115-9922-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product24/02/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079108 02/24/2014
Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0115-9920
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 HYDROCHLORIDE15 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)
D&C RED NO. 28(UNII: 767IP0Y5NH)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
Product Characteristics
Color pink (LIGHT), white Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code IX;684
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0115-9920-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product11/11/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079108 11/11/2014
Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0115-9919
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
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)
AMARANTH(UNII: 37RBV3X49K)
Product Characteristics
Color white, purple (dark purple) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code IX;683
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0115-9919-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product08/06/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079108 08/06/2015
Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0115-9918
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
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)
FD&C RED NO. 3(UNII: PN2ZH5LOQY)
Product Characteristics
Color white, purple (light) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code IX;682
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0115-9918-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product08/06/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079108 08/06/2015
Dexmethylphenidate hydrochlorideDexmethylphenidate hydrochloride CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0115-9921
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 HYDROCHLORIDE20 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)
D&C RED NO. 33(UNII: 9DBA0SBB0L)
D&C RED NO. 28(UNII: 767IP0Y5NH)
Product Characteristics
Color white, pink (dark) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code IX;685
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0115-9921-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product21/12/2015
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA079108 12/21/2015

LABELER - Amneal Pharmaceuticals of New York LLC(123797875)

PRINCIPAL DISPLAY PANEL

NDC 0115-9918-01

CII

Dexmethylphenidate HCl Extended-Release Capsules, 5 mg

Rx only
100 Capsules

5mg label

PRINCIPAL DISPLAY PANEL

NDC 0115-9919-01

CII

Dexmethylphenidate HCl Extended-Release Capsules, 10 mg

Rx only
100 Capsules

10 mg label

PRINCIPAL DISPLAY PANEL

NDC 0115-9920-01

CII

Dexmethylphenidate HCl Extended-Release Capsules, 15 mg

Rx only
100 Capsules

 

15mg label

  

PRINCIPAL DISPLAY PANEL

NDC 0115-9921-01

CII

Dexmethylphenidate HCl Extended-Release Capsules, 20 mg

Rx only
100 Capsules

 

20mg label

  

PRINCIPAL DISPLAY PANEL

NDC 0115-9922-01

CII

Dexmethylphenidate HCl Extended-Release Capsules, 30 mg

Rx only
100 Capsules

30mg label