FDA Product

Tramadol Hydrochloride

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

Basic Information

Product Name

Tramadol Hydrochloride

FDA Product Code

63874-532

Regulatory Information

NDC Product Code

63874-532

Application Number

ANDA076003

Marketing Category

C73584

Effective Date

April 9, 2010

Territorial Authority

USA

FDA Title

Tramadol Hydrochloride Tablets

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

2

Company Information

ManufacturerAltura Pharmaceuticals, Inc.

DUNS Number

006890545

Active Ingredients

TRAMADOL HYDROCHLORIDE

Quantity: 50 mg in 1 1

Code: 9N7R477WCK

Class Code: ACTIB

Active Moieties

TRAMADOL

Code: 39J1LGJ30J

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