NDC Code(s) : 0115-1486-01, 0115-1487-01, 0115-1488-01, 0115-1489-01, 0115-1490-01, 0115-1491-01
Packager : Amneal Pharmaceuticals of New York LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0115-1486
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SACCHARATE(UNII: G83415V073)
(DEXTROAMPHETAMINE - UNII:TZ47U051FI) 		DEXTROAMPHETAMINE SACCHARATE1.25 mg
AMPHETAMINE ASPARTATE MONOHYDRATE(UNII: O1ZPV620O4)
(AMPHETAMINE - UNII:CK833KGX7E) 		AMPHETAMINE ASPARTATE MONOHYDRATE1.25 mg
DEXTROAMPHETAMINE SULFATE(UNII: JJ768O327N)
(DEXTROAMPHETAMINE - UNII:TZ47U051FI) 		DEXTROAMPHETAMINE SULFATE1.25 mg
AMPHETAMINE SULFATE(UNII: 6DPV8NK46S)
(AMPHETAMINE - UNII:CK833KGX7E) 		AMPHETAMINE SULFATE1.25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
HYPROMELLOSE 2910 (50 MPA.S)(UNII: 1IVH67816N)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(UNII: NX76LV5T8J)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
FERRIC OXIDE RED(UNII: 1K09F3G675)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
GELATIN(UNII: 2G86QN327L)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
SHELLAC(UNII: 46N107B71O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
AMMONIA(UNII: 5138Q19F1X)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
Product Characteristics
Color brown (clear, natural), turquoise (light turquoise blue opaque) Score no score
Shape CAPSULE Size 16 mm
Flavor Imprint Code G451
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0115-1486-01100 in 1 BOTTLE Type 0: Not a Combination Product16/02/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076852 02/16/2016
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0115-1487
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SACCHARATE(UNII: G83415V073)
(DEXTROAMPHETAMINE - UNII:TZ47U051FI) 		DEXTROAMPHETAMINE SACCHARATE2.5 mg
AMPHETAMINE ASPARTATE MONOHYDRATE(UNII: O1ZPV620O4)
(AMPHETAMINE - UNII:CK833KGX7E) 		AMPHETAMINE ASPARTATE MONOHYDRATE2.5 mg
DEXTROAMPHETAMINE SULFATE(UNII: JJ768O327N)
(DEXTROAMPHETAMINE - UNII:TZ47U051FI) 		DEXTROAMPHETAMINE SULFATE2.5 mg
AMPHETAMINE SULFATE(UNII: 6DPV8NK46S)
(AMPHETAMINE - UNII:CK833KGX7E) 		AMPHETAMINE SULFATE2.5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
HYPROMELLOSE 2910 (50 MPA.S)(UNII: 1IVH67816N)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(UNII: NX76LV5T8J)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
FERRIC OXIDE RED(UNII: 1K09F3G675)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
GELATIN(UNII: 2G86QN327L)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
SHELLAC(UNII: 46N107B71O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
AMMONIA(UNII: 5138Q19F1X)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
Product Characteristics
Color turquoise (light turquoise blue), turquoise (light turquoise blue opaque) Score no score
Shape CAPSULE Size 16 mm
Flavor Imprint Code G452
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0115-1487-01100 in 1 BOTTLE Type 0: Not a Combination Product16/02/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076852 02/16/2016
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0115-1488
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SACCHARATE(UNII: G83415V073)
(DEXTROAMPHETAMINE - UNII:TZ47U051FI) 		DEXTROAMPHETAMINE SACCHARATE3.75 mg
AMPHETAMINE ASPARTATE MONOHYDRATE(UNII: O1ZPV620O4)
(AMPHETAMINE - UNII:CK833KGX7E) 		AMPHETAMINE ASPARTATE MONOHYDRATE3.75 mg
DEXTROAMPHETAMINE SULFATE(UNII: JJ768O327N)
(DEXTROAMPHETAMINE - UNII:TZ47U051FI) 		DEXTROAMPHETAMINE SULFATE3.75 mg
AMPHETAMINE SULFATE(UNII: 6DPV8NK46S)
(AMPHETAMINE - UNII:CK833KGX7E) 		AMPHETAMINE SULFATE3.75 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
HYPROMELLOSE 2910 (50 MPA.S)(UNII: 1IVH67816N)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(UNII: NX76LV5T8J)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
FERRIC OXIDE RED(UNII: 1K09F3G675)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
GELATIN(UNII: 2G86QN327L)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
SHELLAC(UNII: 46N107B71O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
AMMONIA(UNII: 5138Q19F1X)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
Product Characteristics
Color turquoise (light turquoise blue), white (white opaque) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code G453
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0115-1488-01100 in 1 BOTTLE Type 0: Not a Combination Product16/02/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076852 02/16/2016
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0115-1489
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SACCHARATE(UNII: G83415V073)
(DEXTROAMPHETAMINE - UNII:TZ47U051FI) 		DEXTROAMPHETAMINE SACCHARATE5 mg
AMPHETAMINE ASPARTATE MONOHYDRATE(UNII: O1ZPV620O4)
(AMPHETAMINE - UNII:CK833KGX7E) 		AMPHETAMINE ASPARTATE MONOHYDRATE5 mg
DEXTROAMPHETAMINE SULFATE(UNII: JJ768O327N)
(DEXTROAMPHETAMINE - UNII:TZ47U051FI) 		DEXTROAMPHETAMINE SULFATE5 mg
AMPHETAMINE SULFATE(UNII: 6DPV8NK46S)
(AMPHETAMINE - UNII:CK833KGX7E) 		AMPHETAMINE SULFATE5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
HYPROMELLOSE 2910 (50 MPA.S)(UNII: 1IVH67816N)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(UNII: NX76LV5T8J)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
FERRIC OXIDE RED(UNII: 1K09F3G675)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
GELATIN(UNII: 2G86QN327L)
SHELLAC(UNII: 46N107B71O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
AMMONIA(UNII: 5138Q19F1X)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
Product Characteristics
Color brown (light brown), brown (light brown opaque) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code G454
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0115-1489-01100 in 1 BOTTLE Type 0: Not a Combination Product16/02/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076852 02/16/2016
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0115-1490
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SACCHARATE(UNII: G83415V073)
(DEXTROAMPHETAMINE - UNII:TZ47U051FI) 		DEXTROAMPHETAMINE SACCHARATE6.25 mg
AMPHETAMINE ASPARTATE MONOHYDRATE(UNII: O1ZPV620O4)
(AMPHETAMINE - UNII:CK833KGX7E) 		AMPHETAMINE ASPARTATE MONOHYDRATE6.25 mg
DEXTROAMPHETAMINE SULFATE(UNII: JJ768O327N)
(DEXTROAMPHETAMINE - UNII:TZ47U051FI) 		DEXTROAMPHETAMINE SULFATE6.25 mg
AMPHETAMINE SULFATE(UNII: 6DPV8NK46S)
(AMPHETAMINE - UNII:CK833KGX7E) 		AMPHETAMINE SULFATE6.25 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
HYPROMELLOSE 2910 (50 MPA.S)(UNII: 1IVH67816N)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(UNII: NX76LV5T8J)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
FERRIC OXIDE RED(UNII: 1K09F3G675)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
GELATIN(UNII: 2G86QN327L)
SHELLAC(UNII: 46N107B71O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
AMMONIA(UNII: 5138Q19F1X)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
Product Characteristics
Color brown (light brown), white (white opaque) Score no score
Shape CAPSULE Size 21 mm
Flavor Imprint Code G455
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0115-1490-01100 in 1 BOTTLE Type 0: Not a Combination Product16/02/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076852 02/16/2016
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0115-1491
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SACCHARATE(UNII: G83415V073)
(DEXTROAMPHETAMINE - UNII:TZ47U051FI) 		DEXTROAMPHETAMINE SACCHARATE7.5 mg
AMPHETAMINE ASPARTATE MONOHYDRATE(UNII: O1ZPV620O4)
(AMPHETAMINE - UNII:CK833KGX7E) 		AMPHETAMINE ASPARTATE MONOHYDRATE7.5 mg
DEXTROAMPHETAMINE SULFATE(UNII: JJ768O327N)
(DEXTROAMPHETAMINE - UNII:TZ47U051FI) 		DEXTROAMPHETAMINE SULFATE7.5 mg
AMPHETAMINE SULFATE(UNII: 6DPV8NK46S)
(AMPHETAMINE - UNII:CK833KGX7E) 		AMPHETAMINE SULFATE7.5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
HYPROMELLOSE 2910 (5 MPA.S)(UNII: R75537T0T4)
HYPROMELLOSE 2910 (6 MPA.S)(UNII: 0WZ8WG20P6)
HYPROMELLOSE 2910 (50 MPA.S)(UNII: 1IVH67816N)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER(UNII: NX76LV5T8J)
POLYDEXTROSE(UNII: VH2XOU12IE)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
FERRIC OXIDE RED(UNII: 1K09F3G675)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
GELATIN(UNII: 2G86QN327L)
SHELLAC(UNII: 46N107B71O)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
AMMONIA(UNII: 5138Q19F1X)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
Product Characteristics
Color brown (clear, natural), brown (light brown opaque) Score no score
Shape CAPSULE Size 21 mm
Flavor Imprint Code G456
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0115-1491-01100 in 1 BOTTLE Type 0: Not a Combination Product16/02/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076852 02/16/2016

LABELER - Amneal Pharmaceuticals of New York LLC(123797875)

Establishment
Name Address ID/FEI Business Operations
Amneal Pharmaceuticals of New York, LLC 123797875 label(0115-1486, 0115-1487, 0115-1488, 0115-1489, 0115-1490, 0115-1491), pack(0115-1486, 0115-1487, 0115-1488, 0115-1489, 0115-1490, 0115-1491)

Establishment
Name Address ID/FEI Business Operations
Catalent Pharma Solutions, LLC 829672745 analysis(0115-1486, 0115-1487, 0115-1488, 0115-1489, 0115-1490, 0115-1491), manufacture(0115-1486, 0115-1487, 0115-1488, 0115-1489, 0115-1490, 0115-1491)

Establishment
Name Address ID/FEI Business Operations
CorePharma, LLC 031192276 label(0115-1486, 0115-1487, 0115-1488, 0115-1489, 0115-1490, 0115-1491), pack(0115-1486, 0115-1487, 0115-1488, 0115-1489, 0115-1490, 0115-1490, 0115-1491)

PRINCIPAL DISPLAY PANEL

NDC 0115-1486-01

CII

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules 5 mg

Rx only
100 Capsules


 1

PRINCIPAL DISPLAY PANEL

NDC 0115-1487-01

CII

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules 10 mg

Rx only
100 Capsules

2

PRINCIPAL DISPLAY PANEL

NDC 0115-1488-01

CII

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules 15 mg

Rx only
100 Capsules

3

PRINCIPAL DISPLAY PANEL

NDC 0115-1489-01

CII

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules 20 mg

Rx only
100 Capsules

4

PRINCIPAL DISPLAY PANEL

NDC 0115-1490-01

CII

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules 25 mg

Rx only
100 Capsules

5

PRINCIPAL DISPLAY PANEL

NDC 0115-1491-01

CII

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of a Single-Entity Amphetamine Product) Extended-Release Capsules 30 mg

Rx only
100 Capsules

6