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FDA Product

Amitriptyline Hydrochloride

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

Basic Information

Amitriptyline Hydrochloride

51407-794

Regulatory Information

51407-794

ANDA089399

C73584

November 3, 2023

USA

AMITRIPTYLINE HYDROCHLORIDE TABLETS USP

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

603184490

Active Ingredients

CROSCARMELLOSE SODIUM

Code: M28OL1HH48

Class Code: IACT

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

MICROCRYSTALLINE CELLULOSE

Code: OP1R32D61U

Class Code: IACT

POLYETHYLENE GLYCOL, UNSPECIFIED

Code: 3WJQ0SDW1A

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

ALUMINUM OXIDE

Code: LMI26O6933

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

AMITRIPTYLINE HYDROCHLORIDE

Quantity: 25 mg in 1 1

Code: 26LUD4JO9K

Class Code: ACTIB

FD&C RED NO. 40

Code: WZB9127XOA

Class Code: IACT

POLYVINYL ALCOHOL, UNSPECIFIED

Code: 532B59J990

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

Active Moieties

AMITRIPTYLINE

Code: 1806D8D52K

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