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FDA Drug information

TRAMADOL HYDROCHLORIDE

Read time: 1 mins
Marketing start date: 23 Dec 2024
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Summary of product characteristics


Effective Time

20230927

Version

9

Spl Product Data Elements

TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TRAMADOL HYDROCHLORIDE TRAMADOL ANHYDROUS LACTOSE HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POLYSORBATE 80 SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A POTATO TITANIUM DIOXIDE CELLULOSE, MICROCRYSTALLINE WHITE TO OFF-WHITE ROUND 319

Application Number

ANDA090404

Brand Name

TRAMADOL HYDROCHLORIDE

Generic Name

TRAMADOL HYDROCHLORIDE

Product Ndc

65841-754

Product Type

HUMAN PRESCRIPTION DRUG

Route

ORAL

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Tramadol Hydrochloride Tablets USP, 50 mg NDC 65841-754-01 in bottle of 100 tablets 100 tablets Rx only Tramadol HCl Tablets

Drug section

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