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FDA Drug information

Amitriptyline Hydrochloride

Read time: 1 mins
Marketing start date: 22 Dec 2024
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Summary of product characteristics


Effective Time

20230920

Version

5

Spl Product Data Elements

Amitriptyline Hydrochloride Amitriptyline Hydrochloride AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE LACTOSE MONOHYDRATE CELLULOSE, MICROCRYSTALLINE STARCH, CORN CROSCARMELLOSE SODIUM SILICON DIOXIDE MAGNESIUM STEARATE HYPROMELLOSE 2910 (6 MPA.S) POLYETHYLENE GLYCOL 8000 TITANIUM DIOXIDE TALC OFF-WHITE ROUND ZA;1 Amitriptyline Hydrochloride Amitriptyline Hydrochloride AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE LACTOSE MONOHYDRATE CELLULOSE, MICROCRYSTALLINE STARCH, CORN CROSCARMELLOSE SODIUM SILICON DIOXIDE MAGNESIUM STEARATE HYPROMELLOSE 2910 (6 MPA.S) POLYETHYLENE GLYCOL 8000 TITANIUM DIOXIDE TALC FD&C BLUE NO. 1 D&C YELLOW NO. 10 ALUMINUM OXIDE LIGHT GREEN ROUND ZA;2 Amitriptyline Hydrochloride Amitriptyline Hydrochloride AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE ALUMINUM OXIDE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 FERRIC OXIDE RED FERRIC OXIDE YELLOW HYPROMELLOSE 2910 (6 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL 8000 SILICON DIOXIDE STARCH, CORN TALC TITANIUM DIOXIDE BROWN ROUND ZA;3 Amitriptyline Hydrochloride Amitriptyline Hydrochloride AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM FD&C BLUE NO. 2 FERRIC OXIDE YELLOW HYPROMELLOSE 2910 (6 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL 8000 SILICON DIOXIDE STARCH, CORN TALC TITANIUM DIOXIDE LIGHT BLUE ROUND 12;28 Amitriptyline Hydrochloride Amitriptyline Hydrochloride AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE ALUMINUM OXIDE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM D&C RED NO. 27 D&C YELLOW NO. 10 HYPROMELLOSE 2910 (6 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL 8000 SILICON DIOXIDE STARCH, CORN TALC TITANIUM DIOXIDE ORANGE ROUND 12;29 Amitriptyline Hydrochloride Amitriptyline Hydrochloride AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM FERRIC OXIDE RED FERRIC OXIDE YELLOW HYPROMELLOSE 2910 (6 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL 8000 SILICON DIOXIDE STARCH, CORN TALC TITANIUM DIOXIDE CREAM TO BEIGE MODIFIED CAPSULE 1230

Application Number

ANDA210086

Brand Name

Amitriptyline Hydrochloride

Generic Name

Amitriptyline Hydrochloride

Product Ndc

70771-1175

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1173-1 in bottle of 100 Tablets Amitriptyline Hydrochloride Tablets USP, 10 mg Rx only 100 Tablets NDC 70771-1174-1 in bottle of 100 Tablets Amitriptyline Hydrochloride Tablets USP, 25 mg Rx only 100 Tablets NDC 70771-1175-1 in bottle of 100 Tablets Amitriptyline Hydrochloride Tablets USP, 50 mg Rx only 100 Tablets NDC 70771-1176-1 in bottle of 100 Tablets Amitriptyline Hydrochloride Tablets USP, 75 mg Rx only 100 Tablets NDC 70771-1177-1 in bottle of 100 Tablets Amitriptyline Hydrochloride Tablets USP, 100 mg Rx only 100 Tablets NDC 70771-1178-1 in bottle of 100 Tablets Amitriptyline Hydrochloride Tablets USP, 150 mg Rx only 100 Tablets Amitriptyline Hydrochloride Tablets, USP Amitriptyline Hydrochloride Tablets, USP Amitriptyline Hydrochloride Tablets, USP Amitriptyline Hydrochloride Tablets, USP Amitriptyline Hydrochloride Tablets, USP Amitriptyline Hydrochloride Tablets, USP

Spl Medguide

SPL MEDGUIDE

Drug section

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