Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 5mg (100ct bottle)

NDC 16714-948-01
Dextroamphetamine Saccharate,Amphetamine Aspartate,Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets
(Mixed Salts of a Single Entity Amphetamine Product)
5 mg
Pharmacist: Please dispense with Medication Guide provided separately.
Rx only 100 Tablets

dextro5mg100ct
(click image for full-size original)


dextro5mg100ct

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 7.5 mg (100ct bottle)

NDC 16714-949-01
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets
(Mixed Salts of a Single Entity Amphetamine Product)
7.5 mg
Pharmacist: Please dispense with Medication Guide provided separately.
Rx only 100 Tablets

dextro7.5mg100ct
(click image for full-size original)


dextro7.5mg100ct

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 10 mg (100ct bottle)

NDC 16714-950-01
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets
(Mixed Salts of a Single Entity Amphetamine Product)
10 mg
Pharmacist: Please dispense with Medication Guide provided separately.
Rx only 100 Tablets

dextro10mg100ct
(click image for full-size original)


dextro10mg100ct

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 12.5 mg (100ct bottle)

NDC 16714-951-01
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets
(Mixed Salts of a Single Entity Amphetamine Product)
12.5 mg
Pharmacist: Please dispense with Medication Guide provided separately.
Rx only 100 Tablets

dextro12.5mg100ct
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 15 mg (100ct bottle)

NDC 16714-952-01
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and
Amphetamine Sulfate Tablets
(Mixed Salts of a Single Entity Amphetamine Product)
15 mg
Pharmacist: Please dispense with Medication Guide provided separately.
Rx only 100 Tablets

dextro15mg100ct
(click image for full-size original)


dextro15mg100ct

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 20 mg (100ct bottle)

NDC 16714-953-01
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets
(Mixed Salts of a Single Entity Amphetamine Product)
20 mg
Pharmacist: Please dispense with Medication Guide provided separately.
Rx only 100 Tablets

dextro20mg100ct
(click image for full-size original)


dextro20mg100ct

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 30mg (100ct bottle)

NDC 16714-954-01
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets
(Mixed Salts of a Single Entity Amphetamine Product)
30 mg
Pharmacist: Please dispense with Medication Guide provided separately.
Rx only 100 Tablets

dextro30mg100ct
(click image for full-size original)

dextro30mg100ct
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-948
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SACCHARATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SACCHARATE 1.25 mg
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 1.25 mg
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 1.25 mg
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 1.25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STARCH, CORN
FD&C BLUE NO. 1
Product Characteristics
Color BLUE (light blue to blue) Score 4 pieces
Shape ROUND Size 7mm
Flavor Imprint Code u;25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-948-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202424 03/20/2019
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-949
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SACCHARATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SACCHARATE 1.875 mg
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 1.875 mg
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 1.875 mg
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 1.875 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STARCH, CORN
FD&C BLUE NO. 1
Product Characteristics
Color BLUE (light blue to blue) Score 4 pieces
Shape ROUND Size 8mm
Flavor Imprint Code u;26
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-949-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202424 03/20/2019
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-950
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SACCHARATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SACCHARATE 2.5 mg
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 2.5 mg
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 2.5 mg
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STARCH, CORN
FD&C BLUE NO. 1
Product Characteristics
Color BLUE (light blue to blue) Score 4 pieces
Shape ROUND Size 9mm
Flavor Imprint Code u;27
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-950-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202424 03/20/2019
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-951
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SACCHARATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SACCHARATE 3.125 mg
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 3.125 mg
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 3.125 mg
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 3.125 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STARCH, CORN
FD&C YELLOW NO. 6
Product Characteristics
Color ORANGE (light orange to orange) Score 4 pieces
Shape ROUND Size 7mm
Flavor Imprint Code u;28
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-951-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202424 03/20/2019
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-952
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SACCHARATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SACCHARATE 3.75 mg
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 3.75 mg
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 3.75 mg
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 3.75 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STARCH, CORN
FD&C YELLOW NO. 6
Product Characteristics
Color ORANGE (light orange to orange) Score 4 pieces
Shape ROUND Size 8mm
Flavor Imprint Code u;29
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-952-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202424 03/20/2019
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-953
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SACCHARATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SACCHARATE 5 mg
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 5 mg
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 5 mg
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STARCH, CORN
FD&C YELLOW NO. 6
Product Characteristics
Color ORANGE (light orange to orange) Score 4 pieces
Shape ROUND Size 9mm
Flavor Imprint Code u;30
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-953-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202424 03/20/2019
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-954
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROAMPHETAMINE SACCHARATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SACCHARATE 7.5 mg
AMPHETAMINE ASPARTATE MONOHYDRATE (AMPHETAMINE) AMPHETAMINE ASPARTATE MONOHYDRATE 7.5 mg
DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE) DEXTROAMPHETAMINE SULFATE 7.5 mg
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 7.5 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
STARCH, CORN
FD&C YELLOW NO. 6
Product Characteristics
Color ORANGE (Light Orange to Orange) Score 4 pieces
Shape ROUND Size 10mm
Flavor Imprint Code u;31
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16714-954-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202424 03/20/2019
Labeler — NorthStar RxLLC (830546433)
Establishment
Name Address ID/FEI Operations
Aurolife Pharma LLC 829084461 ANALYSIS (16714-948), ANALYSIS (16714-949), ANALYSIS (16714-950), ANALYSIS (16714-951), ANALYSIS (16714-952), ANALYSIS (16714-953), ANALYSIS (16714-954), LABEL (16714-948), LABEL (16714-949), LABEL (16714-950), LABEL (16714-951), LABEL (16714-952), LABEL (16714-953), LABEL (16714-954), MANUFACTURE (16714-948), MANUFACTURE (16714-949), MANUFACTURE (16714-950), MANUFACTURE (16714-951), MANUFACTURE (16714-952), MANUFACTURE (16714-953), MANUFACTURE (16714-954), PACK (16714-948), PACK (16714-949), PACK (16714-950), PACK (16714-951), PACK (16714-952), PACK (16714-953), PACK (16714-954)

Revised: 09/2019 NorthStar RxLLC

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