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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5 MG TABLET BOTTLE LABEL

NDC 0527-2524 -37

Amphetamine Sulfate Tablets USP,

5 mg

CII

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

Rx only

100 tablets

Manufactured by:

Aavis Pharmaceuticals

Hoschton, GA 30548

Distributed by:

Lannett Company, Inc.

Philadelphia, PA 19136

5mg
(click image for full-size original)

10 MG TABLET BOTTLE LABEL

NDC 0527-2525 -37

Amphetamine Sulfate Tablets USP,

10 mg

CII

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

Rx only

100 tablets

Manufactured by:

Aavis Pharmaceuticals

Hoschton, GA 30548

Distributed by:

Lannett Company, Inc.

Philadelphia, PA 19136

10mg
(click image for full-size original)
AMPHETAMINE SULFATE amphetamine sulfate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-2524
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
STEARIC ACID
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
Product Characteristics
Color WHITE (White to off white) Score 2 pieces
Shape ROUND Size 9mm
Flavor Imprint Code A24
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0527-2524-37 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212901 05/25/2020
AMPHETAMINE SULFATE amphetamine sulfate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-2525
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
STEARIC ACID
CELLULOSE, MICROCRYSTALLINE
SILICON DIOXIDE
FD&C BLUE NO. 1–ALUMINUM LAKE
CROSPOVIDONE
Product Characteristics
Color BLUE Score 4 pieces
Shape ROUND Size 9mm
Flavor Imprint Code A25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0527-2525-37 100 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA212901 05/25/2020
Labeler — Lannett Company, Inc. (002277481)

Revised: 05/2020 Lannett Company, Inc.

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