FDA Product

RYZOLT

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

Basic Information

Product Name

RYZOLT

FDA Product Code

16590-255

Regulatory Information

NDC Product Code

16590-255

Application Number

NDA021745

Marketing Category

C73594

Effective Date

November 19, 2010

Territorial Authority

USA

FDA Title

RYZOLT (tramadol hydrochloride) tablet, extended release

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

3

Company Information

ManufacturerStat Rx USA

DUNS Number

786036330

Active Ingredients

TRAMADOL HYDROCHLORIDE

Quantity: 300 mg in 1 1

Code: 9N7R477WCK

Class Code: ACTIB

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

XANTHAN GUM

Code: TTV12P4NEE

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

Active Moieties

TRAMADOL

Code: 39J1LGJ30J

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