NDC Code(s) : 68382-512-06, 68382-512-01, 68382-512-05, 68382-512-30, 68382-512-77
Packager : Zydus Pharmaceuticals (USA) Inc.

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:68382-512
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:68382-512-0630 in 1 BOTTLE Type 0: Not a Combination Product08/04/2016
2NDC:68382-512-01100 in 1 BOTTLE Type 0: Not a Combination Product08/04/2016
3NDC:68382-512-05500 in 1 BOTTLE Type 0: Not a Combination Product08/04/2016
4NDC:68382-512-7710 in 1 CARTON 08/04/2016
4NDC:68382-512-3010 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 Pharmaceuticals (USA) Inc.(156861945)

REGISTRANT - Zydus Pharmaceuticals (USA) Inc.(156861945)

Establishment
Name Address ID/FEI Business Operations
Zydus Lifesciences Limited 863362789 ANALYSIS(68382-512), MANUFACTURE(68382-512)

PRINCIPAL DISPLAY PANEL

Amantadine Hydrochloride Capsules, USP

NDC 68382-512-01 in bottles of 100 capsules

100 Capsules

Rx only

Zydus

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