MedPath
FDA Product

Amitriptyline HCL

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Amitriptyline HCL

72189-431

Regulatory Information

72189-431

ANDA214548

C73584

March 31, 2023

USA

Amitriptyline HCL

HUMAN PRESCRIPTION DRUG LABEL

4

Company Information

Direct_Rx

079254320

Active Ingredients

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

FD&C BLUE NO. 1 ALUMINUM LAKE

Code: J9EQA3S2JM

Class Code: IACT

HYDROXYPROPYL CELLULOSE (110000 WAMW)

Code: 5Y0974F5PW

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

AMITRIPTYLINE HYDROCHLORIDE

Quantity: 10 mg in 1 1

Code: 26LUD4JO9K

Class Code: ACTIB

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

D&C RED NO. 27 ALUMINUM LAKE

Code: ZK64F7XSTX

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

HYPROMELLOSE 2910 (6 MPA.S)

Code: 0WZ8WG20P6

Class Code: IACT

POLYETHYLENE GLYCOL 400

Code: B697894SGQ

Class Code: IACT

Active Moieties

AMITRIPTYLINE

Code: 1806D8D52K

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