DEXTROAMPHETAMINE SULFATE: Package Insert and Label Information (Page 3 of 3)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 5 mg (100 Tablet Bottle)

NDC 13107-035-01
Dextroamphetamine Sulfate Tablets, USP CII
5 mg
Pharmacist: Please dispense with Medication
Guide provide separately.
Rx only 100 Tablets
AUROBINDO

dextroamphetamine5mg
(click image for full-size original)

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL — 10 mg (100 Tablet Bottle)

NDC 13107-036-01
Dextroamphetamine Sulfate Tablets, USP CII
10 mg
Pharmacist: Please dispense with Medication
Guide provide separately.
Rx only 100 Tablets
AUROBINDO

dextroamphetamine10mg
(click image for full-size original)
DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13107-035
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
FD&C RED NO. 40
FD&C YELLOW NO. 6
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
Product Characteristics
Color ORANGE (Light orange to orange) Score 2 pieces
Shape ROUND (Mottled, Round, Flat-faced, Beveled edge) Size 8mm
Flavor Imprint Code U38
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13107-035-50 50 TABLET in 1 BOTTLE None
2 NDC:13107-035-01 100 TABLET in 1 BOTTLE None
3 NDC:13107-035-99 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202893 07/31/2013
DEXTROAMPHETAMINE SULFATE dextroamphetamine sulfate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13107-036
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
FD&C RED NO. 40
FD&C YELLOW NO. 6
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
Product Characteristics
Color ORANGE (Light orange to orange) Score 2 pieces
Shape ROUND (Mottled, Round, Flat-faced, Beveled edge) Size 10mm
Flavor Imprint Code U39
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13107-036-50 50 TABLET in 1 BOTTLE None
2 NDC:13107-036-01 100 TABLET in 1 BOTTLE None
3 NDC:13107-036-99 1000 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202893 07/31/2013
Labeler — Aurolife Pharma, LLC (829084461)
Establishment
Name Address ID/FEI Operations
Aurolife Pharma, LLC 829084461 MANUFACTURE (13107-035), MANUFACTURE (13107-036)

Revised: 01/2022 Aurolife Pharma, LLC

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