TRAMADOL HYDROCHLORIDE

Product NDC

61786-487

11-digit product format

617860487

Labeler code

61786

Product ID

61786-487_6d77da28-70ca-14a2-e053-2991aa0ab54f

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Tramadol hydrochloride

Dosage form

TABLET

Route

ORAL

Labeler

REMEDYREPACK INC.

Application

ANDA091498

Marketing category

ANDA

Marketing start

2015-11-24

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

2019-12-31

Current FDA listing

Historical FDA.report record