NDC Code(s) : 42806-339-01, 42806-341-01, 42806-343-01, 42806-344-01, 42806-345-01
Packager : Epic Pharma, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42806-339
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
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
D&C RED NO. 27(UNII: 2LRS185U6K)
Product Characteristics
Color BLUE (flat-faced) Score 4 pieces
Shape ROUND (round) Size 7 mm
Flavor Imprint Code E;above;339
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42806-339-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product17/08/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040444 08/17/2018
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42806-341
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
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
D&C RED NO. 27(UNII: 2LRS185U6K)
Product Characteristics
Color BLUE (biconvex) Score 4 pieces
Shape ROUND (round) Size 7 mm
Flavor Imprint Code E;above;341
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42806-341-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product15/03/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040444 03/15/2019
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42806-343
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
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
D&C RED NO. 27(UNII: 2LRS185U6K)
Product Characteristics
Color PINK Score 4 pieces
Shape OVAL Size 11 mm
Flavor Imprint Code E343
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42806-343-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product17/08/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040444 08/17/2018
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42806-344
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
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
D&C RED NO. 27(UNII: 2LRS185U6K)
Product Characteristics
Color PINK (biconvex) Score 4 pieces
Shape ROUND Size 10 mm
Flavor Imprint Code E;above;344
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42806-344-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product15/03/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040444 03/15/2019
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine SulfateDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42806-345
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
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
STARCH, CORN(UNII: O8232NY3SJ)
D&C RED NO. 27(UNII: 2LRS185U6K)
Product Characteristics
Color PINK (flat-faced) Score 4 pieces
Shape ROUND (round) Size 10 mm
Flavor Imprint Code E;above;345
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42806-345-01100 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product17/08/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040444 08/17/2018

LABELER - Epic Pharma, LLC(827915443)

REGISTRANT - EPIC Pharma, LLC(827915443)

Establishment
Name Address ID/FEI Business Operations
Epic Pharma, LLC 827915443 MANUFACTURE(42806-339, 42806-341, 42806-343, 42806-344, 42806-345)

PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

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PRINCIPAL DISPLAY PANEL

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