Amphetamine Sulfate (Page 4 of 4)

PRINCIPAL DISPLAY PANEL

ingenus

NDC 50742-651-01

CII

Amphetamine Sulfate Tablets USP, 5 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx Only

1 00 Tablets

5 mg Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

ingenus

NDC 50742-652-01

CII

Amphetamine Sulfate Tablets USP, 10 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx Only

100 Tablets

10 mg Label
(click image for full-size original)
AMPHETAMINE SULFATE
amphetamine sulfate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50742-651
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 5 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code 651
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50742-651-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213763 08/24/2020
AMPHETAMINE SULFATE
amphetamine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50742-652
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMPHETAMINE SULFATE (AMPHETAMINE) AMPHETAMINE SULFATE 10 mg
Inactive Ingredients
Ingredient Name Strength
CROSPOVIDONE
FD&C YELLOW NO. 6
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
Product Characteristics
Color pink (Peach) Score 4 pieces
Shape ROUND Size 8mm
Flavor Imprint Code 652
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50742-652-01 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213763 08/24/2020
Labeler — Ingenus Pharmaceuticals, LLC (833250017)
Registrant — Novast Laboratories, Ltd. (527695995)
Establishment
Name Address ID/FEI Operations
Ingenus Pharmaceuticals NJ, LLC 964680206 manufacture (50742-651), manufacture (50742-652)

Revised: 12/2020 Ingenus Pharmaceuticals, LLC

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