Dextroamphetamine sulfateextended-release capsule, extended release

Ingredients and appearance - Product information

Dextroamphetamine sulfateextended-release capsule, extended release- Dextroamphetamine sulfate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 54505-327
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)
Ethylcellulose (100 mpa.s) ( UNII: 47MLB0F1MV)
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 YELLOW (yellow cap and a clear body) Imprint Code 327;CP;5mg
Score 1 Shape CAPSULE
Size 14 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 54505-327-09 90 in 1 BOTTLE 1976/08/02

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA AUTHORIZED GENERIC NDA017078 USA 1976/08/02

Dextroamphetamine sulfateextended-release capsule, extended release- Dextroamphetamine sulfate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 54505-328
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)
Ethylcellulose (100 mpa.s) ( UNII: 47MLB0F1MV)
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 ORANGE (orange cap and a clear body) Imprint Code 328;CP;10mg
Score 1 Shape CAPSULE
Size 14 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 54505-328-09 90 in 1 BOTTLE 1976/08/02

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA AUTHORIZED GENERIC NDA017078 USA 1976/08/02

Dextroamphetamine sulfateextended-release capsule, extended release- Dextroamphetamine sulfate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 54505-329
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)
Ethylcellulose (100 mpa.s) ( UNII: 47MLB0F1MV)
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 RED (red cap and a clear body) Imprint Code 329;CP;15mg
Score 1 Shape CAPSULE
Size 16 mm

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 54505-329-09 90 in 1 BOTTLE 1976/08/02

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA AUTHORIZED GENERIC NDA017078 USA 1976/08/02

Labeler - Lineage Therapeutics Inc( 078677620)