Dextroamphetamine Sulfate (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZyGenerics

NDC 68382-943-01 CII

Dextroamphetamine Sulfate Extended-Release Capsules

5 mg

Federal Law requires dispensing of Dextroamphetamine Sulfate Extended-Release Capsules with the Medication Guide provided with this bottle.

100 Capsules

Rx Only

Bottle Label 5 mg

Bottle Label 5 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZyGenerics

NDC 68382-944-01 CII

Dextroamphetamine Sulfate Extended-Release Capsules

10 mg*

Federal Law requires dispensing of Dextroamphetamine Sulfate Extended-Release Capsules with the Medication Guide provided with this bottle.

100 Capsules

Rx Only

10 mg Bottle Label

10 mg Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZyGenerics

NDC 68382-945-01 CII

Dextroamphetamine Sulfate Extended-Release Capsules

15 mg*

Federal Law requires dispensing of Dextroamphetamine Sulfate Extended-Release Capsules with the Medication Guide provided with this bottle.

100 Capsules

Rx Only

15 mg Bottle Label

15 mg Bottle Label

DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-943
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
D&C YELLOW NO. 10
DIBUTYL SEBACATE
ETHYLCELLULOSE (20 MPA.S)
FD&C BLUE NO. 1
FD&C RED NO. 40
FERROSOFERRIC OXIDE
GELATIN
OLEIC ACID
POVIDONE K30
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
SODIUM LAURYL SULFATE
STARCH, CORN
SUCROSE
TALC
TITANIUM DIOXIDE
WATER
Product Characteristics
Color BROWN, BROWN Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code N;943
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68382-943-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209111 06/28/2017
DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-944
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
D&C YELLOW NO. 10
DIBUTYL SEBACATE
ETHYLCELLULOSE (20 MPA.S)
FD&C BLUE NO. 1
FD&C RED NO. 40
FERROSOFERRIC OXIDE
GELATIN
OLEIC ACID
POVIDONE K30
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
SODIUM LAURYL SULFATE
STARCH, CORN
SUCROSE
TALC
TITANIUM DIOXIDE
WATER
Product Characteristics
Color WHITE, BROWN Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code N;944
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68382-944-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209111 06/28/2017
DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68382-945
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
D&C YELLOW NO. 10
DIBUTYL SEBACATE
ETHYLCELLULOSE (20 MPA.S)
FD&C BLUE NO. 1
FD&C RED NO. 40
FERROSOFERRIC OXIDE
GELATIN
OLEIC ACID
POVIDONE K30
PROPYLENE GLYCOL
SHELLAC
SILICON DIOXIDE
SODIUM LAURYL SULFATE
STARCH, CORN
SUCROSE
TALC
TITANIUM DIOXIDE
WATER
Product Characteristics
Color WHITE, BROWN Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code N;945
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68382-945-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209111 06/28/2017
Labeler — Zydus Pharmaceuticals (USA) Inc. (156861945)
Registrant — Nesher Pharmaceuticals (USA) LLC (969028351)
Establishment
Name Address ID/FEI Operations
Nesher Pharmaceuticals (USA) LLC 969028351 ANALYSIS (68382-943), ANALYSIS (68382-944), ANALYSIS (68382-945), MANUFACTURE (68382-943), MANUFACTURE (68382-944), MANUFACTURE (68382-945)

Revised: 12/2021 Zydus Pharmaceuticals (USA) Inc.

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