Amantadine (Page 4 of 4)

HOW SUPPLIED

Amantadine hydrochloride tablets are available as peach color, round, flat face, beveled-edge mottled tablets, debossed with ‘L 75’ on one side and plain on other side as follows:

Bottle of 100 tablets with child resistant closure, NDC 46708-586-31

Bottle of 500 tablets, NDC 46708-586-71

Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Dispense in a tight container as defined in the USP, with a child-resistant closure (as required).

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.

Brands listed are trademarks of their respective owners.
Manufactured by:
Alembic Pharmaceuticals Limited
(Formulation Division),
Village Panelav, P. O. Tajpura,
Near Baska, Taluka-Halol,
Panchmahal, Gujarat, India.
Revised: 10/2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 100 mg

NDC 46708-586-31
Amantadine
Hydrochloride
Tablets
100 mg
Rx only
100 Tablets
Alembic

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AMANTADINE amantadine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:46708-586
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
MICROCRYSTALLINE CELLULOSE
POVIDONE K30
POVIDONE K90
SODIUM STARCH GLYCOLATE TYPE A POTATO
SILICON DIOXIDE
MAGNESIUM STEARATE
FD&C YELLOW NO. 6
Product Characteristics
Color ORANGE (Peach) Score no score
Shape ROUND (flat face) Size 7mm
Flavor Imprint Code L75
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46708-586-31 100 TABLET in 1 BOTTLE None
2 NDC:46708-586-71 500 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214284 10/20/2020
Labeler — Alembic Pharmaceuticals Limited (650574663)
Establishment
Name Address ID/FEI Operations
Alembic Pharmaceuticals Limited 650574671 MANUFACTURE (46708-586)

Revised: 10/2020 Alembic Pharmaceuticals Limited

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