Amantadine Hydrochloride (Page 4 of 4)

HOW SUPPLIED

Amantadine hydrochloride capsules, USP for oral administration are available as:

100 mg: Yellow to pale yellow capsules imprinted 100 and supplied as:

NDC 64380-862-06 bottles of 100

NDC 64380-862-07 bottles of 500

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

Dispense in a tight, light-resistant container as defined in the USP. Protect from moisture.

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:

Strides Pharma Science Limited

Bengaluru-562106, India.

Distributed by:

Strides Pharma Inc.

East Brunswick, NJ 08816

Revised: 07/2023

PRINCIPAL DISPLAY PANEL

Amantadine Hydrochloride Capsules, USP

100 mg

Rx Only

100 Capsules

100 mg 100 Capsules
(click image for full-size original)
AMANTADINE HYDROCHLORIDE
amantadine hydrochloride capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64380-862
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
FERRIC OXIDE YELLOW
GELATIN
GLYCERIN
LECITHIN, SOYBEAN
MEDIUM-CHAIN TRIGLYCERIDES
SOYBEAN OIL
TITANIUM DIOXIDE
WHITE WAX
HYDROGENATED COTTONSEED OIL
SORBITAN
SORBITOL
SHELLAC
FERROSOFERRIC OXIDE
DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W; 1000000 PA.S)
PROPYLENE GLYCOL
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code 100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64380-862-06 100 CAPSULE, LIQUID FILLED in 1 BOTTLE None
2 NDC:64380-862-07 500 CAPSULE, LIQUID FILLED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA211354 12/01/2022
Labeler — Strides Pharma Science Limited (650738743)

Revised: 07/2023 Strides Pharma Science Limited

Page 4 of 4 1 2 3 4

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.