NDC Code(s) : 71335-0469-1, 71335-0469-2, 71335-0469-3, 71335-0469-4, 71335-0469-5
Packager : Bryant Ranch Prepack

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:71335-0469(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
MICROCRYSTALLINE CELLULOSE(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, UNSPECIFIED(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:71335-0469-120 in 1 BOTTLE Type 0: Not a Combination Product27/12/2021
2NDC:71335-0469-230 in 1 BOTTLE Type 0: Not a Combination Product30/08/2021
3NDC:71335-0469-310 in 1 BOTTLE Type 0: Not a Combination Product27/12/2021
4NDC:71335-0469-414 in 1 BOTTLE Type 0: Not a Combination Product22/10/2018
5NDC:71335-0469-560 in 1 BOTTLE Type 0: Not a Combination Product08/05/2020
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA208278 08/04/2016

LABELER - Bryant Ranch Prepack(171714327)

REGISTRANT - Bryant Ranch Prepack(171714327)

Establishment
Name Address ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK(71335-0469), RELABEL(71335-0469)

PRINCIPAL DISPLAY PANEL

Amantadine Hcl 100mg Capsule

Label