DEXEDRINE SPANSULE (Page 5 of 5)

PRINCIPAL DISPLAY PANEL — 15 mg BOTTLE LABEL

1
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 15 mg CARTON

1
(click image for full-size original)
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

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

https://medlibrary.org/lib/rx/meds/dexedrine-spansule/page/5/

Clinical Trials

MedLibrary.org

Medication Sections

RSS Feeds

About

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.