TRAMADOL HYDROCHLORIDE

Product NDC

68788-7609

11-digit product format

687887609

Labeler code

68788

Product ID

68788-7609_7e485986-6e51-4df8-b037-0a9835a77b00

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

TRAMADOL HYDROCHLORIDE

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

Labeler

Preferred Pharmaceuticals, Inc.

Application

ANDA200503

Marketing category

ANDA

Marketing start

2020-02-13

Marketing end

0000-00-00

Substance

TRAMADOL HYDROCHLORIDE

Active strength

100 mg/1

Pharmacologic classes

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

DEA schedule

CIV

NDC exclude flag

No

Listing certified through

2021-12-31

Current FDA listing

Historical FDA.report record