Amphetamine Sulfate (Page 4 of 4)

PRINCIPAL DISPLAY PANEL

NDC 69238-1563-1

Amphetamine Sulfate Tablets USP, 5 mg

CII

Rx Only

100 Tablets

Amneal Pharmaceuticals LLC

5 mg
(click image for full-size original)

NDC 69238-1564-1

Amphetamine Sulfate Tablets USP, 10 mg

CII

Rx Only

100 Tablets

Amneal Pharmaceuticals LLC

10 mg
(click image for full-size original)

5 mg10 mg
AMPHETAMINE SULFATE
amphetamine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1563
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
SILICON DIOXIDE
STEARIC ACID
TALC
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 8mm
Flavor Imprint Code 5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69238-1563-1 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211139 09/28/2018
AMPHETAMINE SULFATE
amphetamine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1564
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 BLUE NO. 1
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
STEARIC ACID
TALC
Product Characteristics
Color BLUE Score 4 pieces
Shape ROUND Size 8mm
Flavor Imprint Code 10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69238-1564-1 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211139 09/28/2018
Labeler — Amneal Pharmaceuticals NY LLC (123797875)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals of New York, LLC 123797875 ANALYSIS (69238-1563), ANALYSIS (69238-1564), LABEL (69238-1563), LABEL (69238-1564), MANUFACTURE (69238-1563), MANUFACTURE (69238-1564), PACK (69238-1563), PACK (69238-1564)

Revised: 12/2020 Amneal Pharmaceuticals NY LLC

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