Dexedrinespansule capsule, extended release

Ingredients and appearance - Product information

Dexedrinespansule capsule, extended release- Dextroamphetamine sulfate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 52054-512
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Dextroamphetamine sulfate ( UNII: JJ768O327N)( Dextroamphetamine - UNII: TZ47U051FI ) 5 mgin 1

Inactive Ingredients

Ingredient Name Code
Cetyl alcohol ( UNII: 936JST6JCN)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Dibutyl sebacate ( UNII: 4W5IH7FLNY)
Ethylcelluloses ( UNII: 7Z8S9VYZ4B)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Gelatin ( UNII: 2G86QN327L)
Hypromelloses ( UNII: 3NXW29V3WO)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
Povidone ( UNII: FZ989GH94E)
Sodium lauryl sulfate ( UNII: 368GB5141J)

Product Characteristics

Color BROWN (brown cap and a clear body) Imprint Code 5mg;512;5mg;ap
Score 1 Shape CAPSULE
Size 14 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA017078 USA

Dexedrinespansule capsule, extended release- Dextroamphetamine sulfate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 52054-513
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Dextroamphetamine sulfate ( UNII: JJ768O327N)( Dextroamphetamine - UNII: TZ47U051FI ) 10 mgin 1

Inactive Ingredients

Ingredient Name Code
Cetyl alcohol ( UNII: 936JST6JCN)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Dibutyl sebacate ( UNII: 4W5IH7FLNY)
Ethylcelluloses ( UNII: 7Z8S9VYZ4B)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Gelatin ( UNII: 2G86QN327L)
Hypromelloses ( UNII: 3NXW29V3WO)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
Povidone ( UNII: FZ989GH94E)
Sodium lauryl sulfate ( UNII: 368GB5141J)

Product Characteristics

Color BROWN (brown cap and a clear body) Imprint Code 10mg;513;10mg;ap
Score 1 Shape CAPSULE
Size 14 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA017078 USA

Dexedrinespansule capsule, extended release- Dextroamphetamine sulfate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 52054-514
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Dextroamphetamine sulfate ( UNII: JJ768O327N)( Dextroamphetamine - UNII: TZ47U051FI ) 15 mgin 1

Inactive Ingredients

Ingredient Name Code
Cetyl alcohol ( UNII: 936JST6JCN)
D&c yellow no. 10 ( UNII: 35SW5USQ3G)
Dibutyl sebacate ( UNII: 4W5IH7FLNY)
Ethylcelluloses ( UNII: 7Z8S9VYZ4B)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Fd&c red no. 40 ( UNII: WZB9127XOA)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
Gelatin ( UNII: 2G86QN327L)
Hypromelloses ( UNII: 3NXW29V3WO)
Polyethylene glycol, unspecified ( UNII: 3WJQ0SDW1A)
Povidone ( UNII: FZ989GH94E)
Sodium lauryl sulfate ( UNII: 368GB5141J)

Product Characteristics

Color BROWN (brown cap and a clear body) Imprint Code 15mg;514;15mg;ap
Score 1 Shape CAPSULE
Size 16 mm

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA017078 USA

Labeler - Amedra Pharmaceuticals LLC( 961668824)