Amantadine Hydrochloride: Package Insert and Label Information (Page 3 of 3)

HOW SUPPLIED:

Amantadine hydrochloride capsules, USP for oral administration are available as: 100 mg size #2 Red Opaque/Red Opaque capsules, imprinted with logo “Lannett” on the cap and “1868” on the body. The capsules are supplied as:

NDC 0527-1868-01 bottles of 100

NDC 0527-1868-05 bottles of 500

Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).

Dispense in a tight container as defined in the USP.

REFERENCES:

1. W.W. Wilson and A.H. Rajput, Amantadine-Dyazide Interaction, Can Med Assoc J. 129:974-975, 1983.
2. D.F. Casey, N. Engl. J. Med. 298:516, 1978.
3. C.D. Berkowitz, J. Pediatr. 95:144, 1979.

Manufactured by:
Lannett Company, Inc.
Philadelphia, PA 19154

CIB71785A

Rev. 05/17

PRINCIPAL DISPLAY PANEL

NDC 0527-1868 -01

Amantadine
Hydrochloride
Capsules, USP

100 mg

Rx Only

100 CAPSULES

Lannett

AMANTADINE HYDROCHLORIDE amantadine hydrochloride capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0527-1868 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMANTADINE HYDROCHLORIDE (AMANTADINE) AMANTADINE HYDROCHLORIDE 100 mg

Inactive Ingredients Ingredient Name Strength STARCH, PREGELATINIZED CORN CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM ETHYLCELLULOSES SODIUM LAURYL SULFATE MAGNESIUM STEARATE WATER GELATIN TITANIUM DIOXIDE FD&C RED NO. 40 SHELLAC ISOPROPYL ALCOHOL AMMONIA BUTYL ALCOHOL PROPYLENE GLYCOL SILICON DIOXIDE

Product Characteristics Color RED Score no score Shape CAPSULE Size 18mm Flavor Imprint Code Lannett;1868 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0527-1868-01 100 CAPSULE in 1 BOTTLE None 2 NDC:0527-1868-05 500 CAPSULE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209221 06/15/2017

Labeler — Lannett Company, Inc. (002277481)

Establishment
Name	Address	ID/FEI	Operations
Lannett Company, Inc.		002277481	MANUFACTURE (0527-1868)

Establishment
Name	Address	ID/FEI	Operations
Lannett Company, Inc.		829757603	ANALYSIS (0527-1868), MANUFACTURE (0527-1868)

Revised: 05/2017 Lannett Company, Inc.