tramadol hydrochloride

Product NDC

16714-481

11-digit product format

167140481

Labeler code

16714

Product ID

16714-481_ad45a83a-1e51-4720-a2ff-3a2a2c8cbf19

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

tramadol hydrochloride

Dosage form

TABLET

Route

ORAL

Labeler

Northstar Rx LLC

Application

ANDA075964

Marketing category

ANDA

Marketing start

2016-04-06

Marketing end

0000-00-00

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

2020-12-31

Current FDA listing

Historical FDA.report record