Basic Information
Amitriptyline Hydrochloride
16571-106
Regulatory Information
16571-106
ANDA217411
C73584
June 22, 2023
USA
Amitriptyline Hydrochloride Tablets, USPRx only
HUMAN PRESCRIPTION DRUG LABEL
1
Company Information
116880195
Active Ingredients
SILICON DIOXIDE
Code: ETJ7Z6XBU4
Class Code: IACT
MICROCRYSTALLINE CELLULOSE 101
Code: 7T9FYH5QMK
Class Code: IACT
MICROCRYSTALLINE CELLULOSE 102
Code: PNR0YF693Y
Class Code: IACT
STARCH, CORN
Code: O8232NY3SJ
Class Code: IACT
HYPROMELLOSE 2910 (6 MPA.S)
Code: 0WZ8WG20P6
Class Code: IACT
POLYETHYLENE GLYCOL 8000
Code: Q662QK8M3B
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
CROSCARMELLOSE SODIUM
Code: M28OL1HH48
Class Code: IACT
HYDROXYPROPYL CELLULOSE (90000 WAMW)
Code: UKE75GEA7F
Class Code: IACT
ISOPROPYL ALCOHOL
Code: ND2M416302
Class Code: IACT
LACTOSE MONOHYDRATE
Code: EWQ57Q8I5X
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
FD&C BLUE NO. 1
Code: H3R47K3TBD
Class Code: IACT
FD&C BLUE NO. 2
Code: L06K8R7DQK
Class Code: IACT
FD&C RED NO. 40
Code: WZB9127XOA
Class Code: IACT
FERRIC OXIDE YELLOW
Code: EX438O2MRT
Class Code: IACT
Active Moieties
AMITRIPTYLINE
Code: 1806D8D52K