NDC Code(s) : 0185-0831-01, 0185-0842-01, 0185-0853-01, 0185-0864-01, 0185-2099-01, 0185-2098-01
Packager : Sandoz Inc

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 TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0185-0831
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
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color BLUE (DARK BLUE) Score 4 pieces
Shape ROUND (ROUND) Size 6 mm
Flavor Imprint Code E;84
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0185-0831-01100 in 1 BOTTLE Type 0: Not a Combination Product20/04/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040439 06/14/2002 09/30/2023
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0185-0842
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
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color BLUE (DARK BLUE) Score 4 pieces
Shape ROUND (ROUND) Size 8 mm
Flavor Imprint Code E;111
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0185-0842-01100 in 1 BOTTLE Type 0: Not a Combination Product20/04/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040439 06/14/2002
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0185-0853
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
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color ORANGE (DARK ORANGE) Score 4 pieces
Shape ROUND (ROUND) Size 8 mm
Flavor Imprint Code E;401
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0185-0853-01100 in 1 BOTTLE Type 0: Not a Combination Product20/04/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040439 06/14/2002
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0185-0864
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
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color ORANGE (DARK ORANGE) Score 4 pieces
Shape ROUND (ROUND) Size 11 mm
Flavor Imprint Code E;404
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0185-0864-01100 in 1 BOTTLE Type 0: Not a Combination Product20/04/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040439 06/14/2002 09/30/2023
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0185-2099
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
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color ORANGE (DARK ORANGE) Score 4 pieces
Shape ROUND (ROUND) Size 10 mm
Flavor Imprint Code E;404
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0185-2099-01100 in 1 BOTTLE Type 0: Not a Combination Product16/11/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040439 06/14/2002
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0185-2098
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
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
Product Characteristics
Color BLUE (DARK BLUE) Score 4 pieces
Shape ROUND (ROUND) Size 6 mm
Flavor Imprint Code E;84
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0185-2098-01100 in 1 BOTTLE Type 0: Not a Combination Product12/08/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040439 06/14/2002

LABELER - Sandoz Inc(005387188)

PRINCIPAL DISPLAY PANEL

NDC 0185-0831-01

Dextroamphetamine Saccharate,

Amphetamine Aspartate,

Dextroamphetamine Sulfate and

Amphetamine Sulfate Tablets

(Mixed Salts of A Single Entity Amphetamine Product)

5 mg

PHARMACIST: Please dispense with

Medication Guide provided separately.

Rx Only

100 Tablets

Sandoz

5mgx100tabs

PRINCIPAL DISPLAY PANEL

NDC 0185-2098-01

Dextroamphetamine Saccharate,

Amphetamine Aspartate,

Dextroamphetamine Sulfate and

Amphetamine Sulfate Tablets

(Mixed Salts of A Single Entity

Amphetamine Product)

5 mg

PHARMACIST: Please dispense with

Medication Guide provided separately.

Rx Only

100 Tablets

Sandoz

5mg-label

PRINCIPAL DISPLAY PANEL

NDC 0185-0842-01

Dextroamphetamine Saccharate,

Amphetamine Aspartate,

Dextroamphetamine Sulfate and

Amphetamine Sulfate Tablets

(Mixed Salts of A Single Entity

Amphetamine Product)

10 mg

PHARMACIST: Please dispense with

Medication Guide provided separately.

Rx Only

100 Tablets

Sandoz

10mg-lbl

PRINCIPAL DISPLAY PANEL

NDC 0185-0853-01

Dextroamphetamine Saccharate,

Amphetamine Aspartate,

Dextroamphetamine Sulfate and

Amphetamine Sulfate Tablets

(Mixed Salts of A Single Entity

Amphetamine Product)

20 mg

PHARMACIST: Please dispense with

Medication Guide provided separately.

Rx Only

100 Tablets

Sandoz

20mg-lbl

PRINCIPAL DISPLAY PANEL

NDC 0185-0864-01

Dextroamphetamine Saccharate,

Amphetamine Aspartate,

Dextroamphetamine Sulfate and

Amphetamine Sulfate Tablets

(Mixed Salts of A Single Entity Amphetamine Product)

30 mg

PHARMACIST: Please dispense with

Medication Guide provided separately.

Rx Only

100 Tablets

Sandoz

30mgx100tabs

PRINCIPAL DISPLAY PANEL

NDC 0185-2099-01

Dextroamphetamine Saccharate,

Amphetamine Aspartate,

Dextroamphetamine Sulfate and

Amphetamine Sulfate Tablets

(Mixed Salts of A Single Entity

Amphetamine Product)

30 mg

PHARMACIST: Please dispense with

Medication Guide provided separately.

Rx Only

100 Tablets

Sandoz

30mg-lbl