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FDA Product

Amitriptyline Hydrochloride

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

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

AMITRIPTYLINE HYDROCHLORIDE

Quantity: 25 mg in 1 1

Code: 26LUD4JO9K

Class Code: ACTIB

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

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