NDC Code(s) : 65841-835-06, 65841-835-01, 65841-835-05, 65841-835-30, 65841-835-77
Packager : Zydus Lifesciences Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

amantadine hydrochlorideamantadine hydrochloride CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-835
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMANTADINE HYDROCHLORIDE(UNII: M6Q1EO9TD0)
(AMANTADINE - UNII:BF4C9Z1J53) 		AMANTADINE HYDROCHLORIDE100 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
ETHYLCELLULOSE (4 MPA.S)(UNII: KC5472WRJK)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
GELATIN(UNII: 2G86QN327L)
MAGNESIUM STEARATE(UNII: 70097M6I30)
POTASSIUM HYDROXIDE(UNII: WZH3C48M4T)
SHELLAC(UNII: 46N107B71O)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
STARCH, CORN(UNII: O8232NY3SJ)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color RED (red opaque colored cap), RED (red opaque colored body) Score no score
Shape CAPSULE Size 18 mm
Flavor Imprint Code 652
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:65841-835-0630 in 1 BOTTLE Type 0: Not a Combination Product08/04/2016
2NDC:65841-835-01100 in 1 BOTTLE Type 0: Not a Combination Product08/04/2016
3NDC:65841-835-05500 in 1 BOTTLE Type 0: Not a Combination Product08/04/2016
4NDC:65841-835-7710 in 1 CARTON 08/04/2016
4NDC:65841-835-3010 in 1 BLISTER PACK Type 0: Not a Combination Product08/04/2016
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208278 08/04/2016

LABELER - Zydus Lifesciences Limited(918596198)

REGISTRANT - Zydus Lifesciences Limited(863362789)

Establishment
Name Address ID/FEI Business Operations
Zydus Lifesciences Limited 863362789 ANALYSIS(65841-835), MANUFACTURE(65841-835)

PRINCIPAL DISPLAY PANEL

Amantadine Hydrochloride Capsules, USP

NDC 65841-835-01 in bottles of 100 capsules

100 Capsules

Rx only

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