DEXEDRINE SPANSULE (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 15 mg BOTTLE LABEL

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PRINCIPAL DISPLAY PANEL — 15 mg CARTON

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DEXEDRINE SPANSULE dextroamphetamine sulfate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64896-673
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 5 mg
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL
D&C YELLOW NO. 10
DIBUTYL SEBACATE
ETHYLCELLULOSES
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
HYPROMELLOSES
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
SODIUM LAURYL SULFATE
Product Characteristics
Color brown (brown cap and natural body) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code IX;5mg;673;5mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64896-673-10 1 BOTTLE in 1 CARTON contains a BOTTLE
1 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE This package is contained within the CARTON (64896-673-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017078 08/02/1976
DEXEDRINE SPANSULE dextroamphetamine sulfate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64896-674
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 10 mg
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL
D&C YELLOW NO. 10
DIBUTYL SEBACATE
ETHYLCELLULOSES
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
HYPROMELLOSES
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
SODIUM LAURYL SULFATE
Product Characteristics
Color brown (brown cap and natural body) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code IX;10mg;674;10mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64896-674-10 1 BOTTLE in 1 CARTON contains a BOTTLE
1 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE This package is contained within the CARTON (64896-674-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017078 08/02/1976
DEXEDRINE SPANSULE dextroamphetamine sulfate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64896-675
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 15 mg
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL
D&C YELLOW NO. 10
DIBUTYL SEBACATE
ETHYLCELLULOSES
FD&C BLUE NO. 1
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
HYPROMELLOSES
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
SODIUM LAURYL SULFATE
Product Characteristics
Color brown (brown cap and natural body) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code IX;15mg;675;15mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64896-675-10 1 BOTTLE in 1 CARTON contains a BOTTLE
1 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE This package is contained within the CARTON (64896-675-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017078 08/02/1976
Labeler — Amneal Pharmaceuticals LLC (123797875)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals of New York, LLC 123797875 pack (64896-673), pack (64896-674), pack (64896-675)
Establishment
Name Address ID/FEI Operations
AndersonBrecon Inc. 053217022 pack (64896-673), pack (64896-674), pack (64896-675)
Establishment
Name Address ID/FEI Operations
Cambrex Charles City, Inc. 782974257 api manufacture (64896-673), api manufacture (64896-674), api manufacture (64896-675)
Establishment
Name Address ID/FEI Operations
Catalent Pharma Solutions 014167995 analysis (64896-673), analysis (64896-674), analysis (64896-675)
Establishment
Name Address ID/FEI Operations
Catalent Pharma Solutions, LLC 829672745 analysis (64896-673), analysis (64896-674), analysis (64896-675), manufacture (64896-673), manufacture (64896-674), manufacture (64896-675)

Revised: 01/2022 Amneal Pharmaceuticals LLC

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