Basic Information
Amantadine Hydrochloride
62135-609
Regulatory Information
62135-609
ANDA209171
C73584
June 26, 2023
USA
Amantadine Hydrochloride Capsules, USP Rx only
HUMAN PRESCRIPTION DRUG LABEL
1
Company Information
079394054
Active Ingredients
STARCH, CORN
Code: O8232NY3SJ
Class Code: IACT
CROSCARMELLOSE SODIUM
Code: M28OL1HH48
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
FD&C BLUE NO. 1
Code: H3R47K3TBD
Class Code: IACT
FD&C RED NO. 40
Code: WZB9127XOA
Class Code: IACT
GELATIN, UNSPECIFIED
Code: 2G86QN327L
Class Code: IACT
SODIUM LAURYL SULFATE
Code: 368GB5141J
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
SHELLAC
Code: 46N107B71O
Class Code: IACT
PROPYLENE GLYCOL
Code: 6DC9Q167V3
Class Code: IACT
ALCOHOL
Code: 3K9958V90M
Class Code: IACT
BUTYL ALCOHOL
Code: 8PJ61P6TS3
Class Code: IACT
POTASSIUM HYDROXIDE
Code: WZH3C48M4T
Class Code: IACT
ISOPROPYL ALCOHOL
Code: ND2M416302
Class Code: IACT
AMMONIA
Code: 5138Q19F1X
Class Code: IACT
MICROCRYSTALLINE CELLULOSE
Code: OP1R32D61U
Class Code: IACT
Active Moieties
AMANTADINE
Code: BF4C9Z1J53