NDC Code(s) : 0228-3062-11, 0228-3059-11, 0228-3063-11, 0228-3060-11, 0228-3064-11, 0228-3061-11
Packager : Actavis Pharma, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfateDextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0228-3062
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
AMMONIO METHACRYLATE COPOLYMER TYPE A(UNII: 8GQS4E66YY)
AMMONIO METHACRYLATE COPOLYMER TYPE B(UNII: 161H3B14U2)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
SUCROSE(UNII: C151H8M554)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
D&C YELLOW NO. 10 ALUMINUM LAKE(UNII: CQ3XH3DET6)
FD&C BLUE NO. 1 ALUMINUM LAKE(UNII: J9EQA3S2JM)
FD&C BLUE NO. 2--ALUMINUM LAKE(UNII: 4AQJ3LG584)
FD&C RED NO. 40(UNII: WZB9127XOA)
SHELLAC(UNII: 46N107B71O)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
Product Characteristics
Color orange, blue (LIGHT) Score no score
Shape CAPSULE Size 16 mm
Flavor Imprint Code R3062
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0228-3062-11100 in 1 BOTTLE Type 0: Not a Combination Product22/06/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077302 06/22/2012
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfateDextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0228-3059
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
AMMONIO METHACRYLATE COPOLYMER TYPE A(UNII: 8GQS4E66YY)
AMMONIO METHACRYLATE COPOLYMER TYPE B(UNII: 161H3B14U2)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
SUCROSE(UNII: C151H8M554)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C YELLOW NO. 10 ALUMINUM LAKE(UNII: CQ3XH3DET6)
FD&C BLUE NO. 1 ALUMINUM LAKE(UNII: J9EQA3S2JM)
FD&C BLUE NO. 2--ALUMINUM LAKE(UNII: 4AQJ3LG584)
FD&C RED NO. 40(UNII: WZB9127XOA)
SHELLAC(UNII: 46N107B71O)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
Product Characteristics
Color white (IVORY), blue (LIGHT) Score no score
Shape CAPSULE Size 16 mm
Flavor Imprint Code R3059
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0228-3059-11100 in 1 BOTTLE Type 0: Not a Combination Product22/06/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077302 06/22/2012
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfateDextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0228-3063
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
AMMONIO METHACRYLATE COPOLYMER TYPE A(UNII: 8GQS4E66YY)
AMMONIO METHACRYLATE COPOLYMER TYPE B(UNII: 161H3B14U2)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
SUCROSE(UNII: C151H8M554)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
D&C YELLOW NO. 10 ALUMINUM LAKE(UNII: CQ3XH3DET6)
FD&C BLUE NO. 1 ALUMINUM LAKE(UNII: J9EQA3S2JM)
FD&C BLUE NO. 2--ALUMINUM LAKE(UNII: 4AQJ3LG584)
FD&C RED NO. 40(UNII: WZB9127XOA)
SHELLAC(UNII: 46N107B71O)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
Product Characteristics
Color white (IVORY), orange Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code R3063
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0228-3063-11100 in 1 BOTTLE Type 0: Not a Combination Product22/06/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077302 06/22/2012
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfateDextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0228-3060
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
AMMONIO METHACRYLATE COPOLYMER TYPE A(UNII: 8GQS4E66YY)
AMMONIO METHACRYLATE COPOLYMER TYPE B(UNII: 161H3B14U2)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
SUCROSE(UNII: C151H8M554)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C YELLOW NO. 10 ALUMINUM LAKE(UNII: CQ3XH3DET6)
FD&C BLUE NO. 1 ALUMINUM LAKE(UNII: J9EQA3S2JM)
FD&C BLUE NO. 2--ALUMINUM LAKE(UNII: 4AQJ3LG584)
FD&C RED NO. 40(UNII: WZB9127XOA)
SHELLAC(UNII: 46N107B71O)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
Product Characteristics
Color blue (LIGHT) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code R3060
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0228-3060-11100 in 1 BOTTLE Type 0: Not a Combination Product22/06/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077302 06/22/2012
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfateDextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0228-3064
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
AMMONIO METHACRYLATE COPOLYMER TYPE A(UNII: 8GQS4E66YY)
AMMONIO METHACRYLATE COPOLYMER TYPE B(UNII: 161H3B14U2)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
SUCROSE(UNII: C151H8M554)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
D&C YELLOW NO. 10(UNII: 35SW5USQ3G)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
D&C YELLOW NO. 10 ALUMINUM LAKE(UNII: CQ3XH3DET6)
FD&C BLUE NO. 1 ALUMINUM LAKE(UNII: J9EQA3S2JM)
FD&C BLUE NO. 2--ALUMINUM LAKE(UNII: 4AQJ3LG584)
FD&C RED NO. 40(UNII: WZB9127XOA)
SHELLAC(UNII: 46N107B71O)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
Product Characteristics
Color white (IVORY) Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code R3064
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0228-3064-11100 in 1 BOTTLE Type 0: Not a Combination Product22/06/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077302 06/22/2012
Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfateDextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0228-3061
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
AMMONIO METHACRYLATE COPOLYMER TYPE A(UNII: 8GQS4E66YY)
AMMONIO METHACRYLATE COPOLYMER TYPE B(UNII: 161H3B14U2)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
SUCROSE(UNII: C151H8M554)
STARCH, CORN(UNII: O8232NY3SJ)
TALC(UNII: 7SEV7J4R1U)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
FERRIC OXIDE RED(UNII: 1K09F3G675)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
D&C YELLOW NO. 10 ALUMINUM LAKE(UNII: CQ3XH3DET6)
FD&C BLUE NO. 1 ALUMINUM LAKE(UNII: J9EQA3S2JM)
FD&C BLUE NO. 2--ALUMINUM LAKE(UNII: 4AQJ3LG584)
FD&C RED NO. 40(UNII: WZB9127XOA)
SHELLAC(UNII: 46N107B71O)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
Product Characteristics
Color orange Score no score
Shape CAPSULE Size 19 mm
Flavor Imprint Code R3061
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0228-3061-11100 in 1 BOTTLE Type 0: Not a Combination Product22/06/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077302 06/22/2012

LABELER - Actavis Pharma, Inc.(119723554)

PRINCIPAL DISPLAY PANEL

NDC 0228-3062-11

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules, CII

(Mixed Salts of a Single Entity Amphetamine Product)

5 mg*

Rx only
100 Capsules

1

PRINCIPAL DISPLAY PANEL

NDC 0228-3059-11

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules, CII

(Mixed Salts of a Single Entity Amphetamine Product)

10 mg*

Rx only
100 Capsules

1

PRINCIPAL DISPLAY PANEL

NDC 0228-3063-11

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules, CII

(Mixed Salts of a Single Entity Amphetamine Product)

15 mg*

Rx only
100 Capsules

1

PRINCIPAL DISPLAY PANEL

NDC 0228-3060-11

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules, CII

(Mixed Salts of a Single Entity Amphetamine Product)

20 mg*

Rx only
100 Capsules

1

PRINCIPAL DISPLAY PANEL

NDC 0228-3064-11

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules, CII

(Mixed Salts of a Single Entity Amphetamine Product)

25 mg*

Rx only
100 Capsules

1

PRINCIPAL DISPLAY PANEL

NDC 0228-3061-11

Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, Amphetamine Sulfate Extended-Release Capsules, CII

(Mixed Salts of a Single Entity Amphetamine Product)

30 mg*

Rx only
100 Capsules

1