NDC Code(s) : 52536-500-01, 52536-500-03, 52536-510-03, 52536-515-03, 52536-520-03, 52536-530-03
Packager : Wilshire Pharmaceuticals, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : CII

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Dextroamphetamine SulfateDextroamphetamine Sulfate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52536-500
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextroamphetamine Sulfate(UNII: JJ768O327N)
(Dextroamphetamine - UNII:TZ47U051FI) 		Dextroamphetamine Sulfate5 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (120 .MU.M)(UNII: 68401960MK)
microcrystalline cellulose(UNII: OP1R32D61U)
stearic acid(UNII: 4ELV7Z65AP)
D&C RED NO. 27(UNII: 2LRS185U6K)
FD&C Yellow NO. 6(UNII: H77VEI93A8)
Product Characteristics
Color PINK Score 2 pieces
Shape OVAL Size 11 mm
Flavor Imprint Code 5;MIA
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52536-500-01100 in 1 BOTTLE Type 0: Not a Combination Product16/07/2012
2NDC:52536-500-0330 in 1 BOTTLE Type 0: Not a Combination Product14/04/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090533 07/16/2012
Dextroamphetamine SulfateDextroamphetamine Sulfate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52536-510
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextroamphetamine Sulfate(UNII: JJ768O327N)
(Dextroamphetamine - UNII:TZ47U051FI) 		Dextroamphetamine Sulfate10 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (120 .MU.M)(UNII: 68401960MK)
microcrystalline cellulose(UNII: OP1R32D61U)
stearic acid(UNII: 4ELV7Z65AP)
FD&C Red NO. 40(UNII: WZB9127XOA)
FD&C Yellow NO. 6(UNII: H77VEI93A8)
FD&C Blue NO. 2(UNII: L06K8R7DQK)
Product Characteristics
Color ORANGE (Peach) Score 4 pieces
Shape ROUND Size 8 mm
Flavor Imprint Code 10;MIA
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52536-510-0330 in 1 BOTTLE Type 0: Not a Combination Product14/04/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090533 07/20/2012
Dextroamphetamine SulfateDextroamphetamine Sulfate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52536-515
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextroamphetamine Sulfate(UNII: JJ768O327N)
(Dextroamphetamine - UNII:TZ47U051FI) 		Dextroamphetamine Sulfate15 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (120 .MU.M)(UNII: 68401960MK)
microcrystalline cellulose(UNII: OP1R32D61U)
stearic acid(UNII: 4ELV7Z65AP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C BLUE NO. 2(UNII: L06K8R7DQK)
FD&C RED NO. 40(UNII: WZB9127XOA)
Product Characteristics
Color BLUE Score no score
Shape PENTAGON (5 sided) Size 8 mm
Flavor Imprint Code 15;MIA
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52536-515-0330 in 1 BOTTLE Type 0: Not a Combination Product08/06/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090533 08/06/2021
Dextroamphetamine SulfateDextroamphetamine Sulfate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52536-520
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextroamphetamine Sulfate(UNII: JJ768O327N)
(Dextroamphetamine - UNII:TZ47U051FI) 		Dextroamphetamine Sulfate20 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (120 .MU.M)(UNII: 68401960MK)
microcrystalline cellulose(UNII: OP1R32D61U)
stearic acid(UNII: 4ELV7Z65AP)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
D&C RED NO. 27(UNII: 2LRS185U6K)
Product Characteristics
Color PURPLE Score no score
Shape OVAL Size 11 mm
Flavor Imprint Code 20;MIA
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52536-520-0330 in 1 BOTTLE Type 0: Not a Combination Product08/06/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090533 08/06/2021
Dextroamphetamine SulfateDextroamphetamine Sulfate TABLET
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52536-530
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dextroamphetamine Sulfate(UNII: JJ768O327N)
(Dextroamphetamine - UNII:TZ47U051FI) 		Dextroamphetamine Sulfate30 mg
Inactive Ingredients
Ingredient Name Strength
silicon dioxide(UNII: ETJ7Z6XBU4)
CROSPOVIDONE (120 .MU.M)(UNII: 68401960MK)
microcrystalline cellulose(UNII: OP1R32D61U)
stearic acid(UNII: 4ELV7Z65AP)
D&C Yellow NO. 10(UNII: 35SW5USQ3G)
Product Characteristics
Color YELLOW (light) Score no score
Shape HEXAGON (6 sided) Size 8 mm
Flavor Imprint Code 30;MIA
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52536-530-0330 in 1 BOTTLE Type 0: Not a Combination Product08/06/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090533 08/06/2021

LABELER - Wilshire Pharmaceuticals, Inc.(078657245)

PRINCIPAL DISPLAY PANEL

NDC 52536-500-03

30 tablets

Dextroamphetamine
Sulfate Tablets, USP
CII

Rx only

5 mg

PHARMACIST: Dispense the Medication
Guide provided separately to each patient.

Marketed by
Wilshire Pharmaceuticals, Inc.
Atlanta, GA 30328

WILSHIRE®
PHARMACEUTICALS, INC

PRINCIPAL DISPLAY PANEL - 5 mg Tablet Bottle Label - 03

PRINCIPAL DISPLAY PANEL

NDC 52536-510-03

30 tablets

Dextroamphetamine
Sulfate Tablets, USP
CII

Rx only

10 mg

PHARMACIST: Dispense the Medication
Guide provided separately to each patient.

Marketed by
Wilshire Pharmaceuticals, Inc.
Atlanta, GA 30328

WILSHIRE®
PHARMACEUTICALS, INC

PRINCIPAL DISPLAY PANEL - 10 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 52536-515-03

30 tablets

Dextroamphetamine
Sulfate Tablets, USP
CII

Rx only

15 mg

PHARMACIST: Dispense the Medication
Guide provided separately to each patient.

Marketed by
Wilshire Pharmaceuticals, Inc.
Atlanta, GA 30328

WILSHIRE®
PHARMACEUTICALS, INC

PRINCIPAL DISPLAY PANEL - 15 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 52536-520-03

30 tablets

Dextroamphetamine
Sulfate Tablets, USP
CII

Rx only

20 mg

PHARMACIST: Dispense the Medication
Guide provided separately to each patient.

Marketed by
Wilshire Pharmaceuticals, Inc.
Atlanta, GA 30328

WILSHIRE®
PHARMACEUTICALS, INC

PRINCIPAL DISPLAY PANEL - 20 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL

NDC 52536-530-03

30 tablets

Dextroamphetamine
Sulfate Tablets, USP
CII

Rx only

30 mg

PHARMACIST: Dispense the Medication
Guide provided separately to each patient.

Marketed by
Wilshire Pharmaceuticals, Inc.
Atlanta, GA 30328

WILSHIRE®
PHARMACEUTICALS, INC

PRINCIPAL DISPLAY PANEL - 30 mg Tablet Bottle Label