Basic Information
Amitriptyline Hydrochloride
16714-448
Regulatory Information
16714-448
ANDA085968
C73584
August 13, 2020
USA
Amitriptyline Hydrochloride Tablets, USP
HUMAN PRESCRIPTION DRUG LABEL
16
Company Information
830546433
Active Ingredients
D&C YELLOW NO. 10
Code: 35SW5USQ3G
Class Code: IACT
MICROCRYSTALLINE CELLULOSE
Code: OP1R32D61U
Class Code: IACT
FD&C RED NO. 40
Code: WZB9127XOA
Class Code: IACT
FD&C BLUE NO. 2
Code: L06K8R7DQK
Class Code: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)
Code: RFW2ET671P
Class Code: IACT
LACTOSE MONOHYDRATE
Code: EWQ57Q8I5X
Class Code: IACT
HYPROMELLOSE, UNSPECIFIED
Code: 3NXW29V3WO
Class Code: IACT
MAGNESIUM STEARATE
Code: 70097M6I30
Class Code: IACT
SILICON DIOXIDE
Code: ETJ7Z6XBU4
Class Code: IACT
POLYETHYLENE GLYCOL, UNSPECIFIED
Code: 3WJQ0SDW1A
Class Code: IACT
TITANIUM DIOXIDE
Code: 15FIX9V2JP
Class Code: IACT
STARCH, CORN
Code: O8232NY3SJ
Class Code: IACT
Active Moieties
AMITRIPTYLINE
Code: 1806D8D52K