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

100 mg 100 count
(click image for full-size original)
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.

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