Minds On Meds

Mental Health Medications

ADHD Medications

Dexedrine, Page 3

Dexedrine is indicated Narcolepsy and in Attention Deficit Disorder with Hyperactivity. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of the hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years.

Principal Display Panel — 5 mg

5 mg  NDC  52054-512-09
DEXEDRINE®
DEXTROAMPHETAMINE SULFATE
SPANSULE®
SUSTAINED-RELEASE CAPSULES
CII
(click image for full-size original)

5 mg NDC 52054-512-09

DEXEDRINE®
DEXTROAMPHETAMINE SULFATE
SPANSULE®
SUSTAINED-RELEASE CAPSULESCII

Principal Display Panel — 10 mg

10 mg NDC 52054-512-09
DEXEDRINE®
DEXTROAMPHETAMINE SULFATE
SPANSULE®
SUSTAINED-RELEASE CAPSULES
CII
(click image for full-size original)

NDC 52054-512-09
10 mg
DEXEDRINE®
DEXTROAMPHETAMINE SULFATE
SPANSULE®
SUSTAINED-RELEASE CAPSULESCII

Principal Display Panel — 15 mg

15 mg NDC 52054-514-09 
DEXEDRINE®
DEXTROAMPHETAMINE SULFATE
SPANSULE®
SUSTAINED-RELEASE CAPSULES 
CII
(click image for full-size original)

15 mg NDC 52054-514-09
DEXEDRINE®
DEXTROAMPHETAMINE SULFATE
SPANSULE®
SUSTAINED-RELEASE CAPSULES CII

DEXEDRINE
dextroamphetamine sulfate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52054-512(NDC:0007-3512)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE 5 mg
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL
D&C YELLOW NO. 10
DIBUTYL SEBACATE
ETHYLCELLULOSE (100 MPA.S)
ALUMINUM OXIDE
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
HYPROMELLOSES
PROPYLENE GLYCOL
POVIDONE
SILICON DIOXIDE
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
Product Characteristics
Color BROWN (brown cap and a clear body) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code 5;mg;3512;5;mg;SB
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52054-512-09 90 BOTTLE, PLASTIC (90 CAPSULE) in 1 CARTON contains a BOTTLE, PLASTIC
1 90 CAPSULE, EXTENDED RELEASE (90 CAPSULE) in 1 BOTTLE, PLASTIC This package is contained within the CARTON (52054-512-09)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017078 11/14/2007
DEXEDRINE
dextroamphetamine sulfate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52054-513(NDC:0007-3513)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE 10 mg
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL
D&C YELLOW NO. 10
DIBUTYL SEBACATE
ETHYLCELLULOSE (100 MPA.S)
ALUMINUM OXIDE
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
HYPROMELLOSES
PROPYLENE GLYCOL
POVIDONE
SILICON DIOXIDE
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
Product Characteristics
Color BROWN (brown cap and a clear body) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code 10;mg;3513;10;mg;SB
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52054-513-09 90 BOTTLE, PLASTIC (90 CARTON) in 1 CARTON contains a BOTTLE, PLASTIC
1 90 CAPSULE, EXTENDED RELEASE (90 CAPSULE) in 1 BOTTLE, PLASTIC This package is contained within the CARTON (52054-513-09)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017078 10/05/2007
DEXEDRINE
dextroamphetamine sulfate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52054-514(NDC:0007-3514)
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE 15 mg
Inactive Ingredients
Ingredient Name Strength
CETYL ALCOHOL
D&C YELLOW NO. 10
DIBUTYL SEBACATE
ETHYLCELLULOSE (100 MPA.S)
ALUMINUM OXIDE
FD&C RED NO. 40
FD&C YELLOW NO. 6
GELATIN
HYPROMELLOSES
PROPYLENE GLYCOL
POVIDONE
SILICON DIOXIDE
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
Product Characteristics
Color BROWN (brown cap and a clear body) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code 15;mg;3514;15;mg;SB
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52054-514-09 90 BOTTLE (90 CAPSULE) in 1 CARTON contains a BOTTLE
1 90 CAPSULE, EXTENDED RELEASE (90 CAPSULE) in 1 BOTTLE This package is contained within the CARTON (52054-514-09)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017078 10/05/2007
Labeler — Amedra Pharmaceuticals (961668824)

Revised: 03/2011 Amedra Pharmaceuticals