Dextroamphetamine Sulfate (Page 4 of 4)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Container Label

5 mg

30 Tablets

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1000 Tablets

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10 mg

30 Tablets

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1000 Tablets

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DEXTROAMPHETAMINE SULFATE
dextroamphetamine sulfate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:40032-870
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
SILICON DIOXIDE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
D&C YELLOW NO. 10
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color ORANGE (peach) Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code n;870
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:40032-870-03 30 TABLET in 1 BOTTLE None
2 NDC:40032-870-01 100 TABLET in 1 BOTTLE None
3 NDC:40032-870-10 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204330 03/16/2016
DEXTROAMPHETAMINE SULFATE
dextroamphetamine sulfate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:40032-871
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
SILICON DIOXIDE
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
FD&C YELLOW NO. 6
FD&C RED NO. 40
Product Characteristics
Color PINK Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code n;871
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:40032-871-03 30 TABLET in 1 BOTTLE None
2 NDC:40032-871-10 1000 TABLET in 1 BOTTLE None
3 NDC:40032-871-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204330 03/16/2016
Labeler — Novel Laboratories, Inc. (793518643)
Registrant — Novel Laboratories, Inc. (793518643)
Establishment
Name Address ID/FEI Operations
Novel Laboratories, Inc. 793518643 ANALYSIS (40032-870), ANALYSIS (40032-871), MANUFACTURE (40032-870), MANUFACTURE (40032-871), PACK (40032-870), PACK (40032-871)

Revised: 12/2017 Novel Laboratories, Inc.

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