Tramadol Hydrochloride

Product NDC

68094-017

11-digit product format

680940017

Labeler code

68094

Product ID

68094-017_9ba23f92-b8fe-43c5-9057-81e2678462b4

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Tramadol Hydrochloride

Dosage form

TABLET, COATED

Route

ORAL

Labeler

Precision Dose, Inc.

Application

ANDA076003

Marketing category

ANDA

Marketing start

2017-11-22

Marketing end

2019-10-31

Substance

TRAMADOL HYDROCHLORIDE

Active strength

50 mg/1

Pharmacologic classes

Full Opioid Agonists [MoA],Opioid Agonist [EPC]

DEA schedule

CIV

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record