Ultram ER

Product NDC

50458-657

11-digit product format

504580657

Labeler code

50458

Product ID

50458-657_96bec1b6-7ff2-4e89-be58-d5c359fb51f4

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Tramadol Hydrochloride

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Labeler

Janssen Pharmaceuticals,

Application

NDA021692

Marketing category

NDA

Marketing start

2005-10-01

Marketing end

0000-00-00

Substance

TRAMADOL HYDROC

Active strength

300 mg/1

Pharmacologic classes

Full Opioid Ago

DEA schedule

CIV

NDC exclude flag

E

Listing certified through

2018-12-31

Current FDA listing

Historical FDA.report record