TRAMADOL HYDROCHLORIDE

Product NDC
50436-0823
11-digit product format
504360823
Labeler code
50436
Product ID
50436-0823_c3ffd953-4cd1-4c9d-b0d0-b4b5fffec802
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tramadol hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA078783
Marketing category
ANDA
Marketing start
2012-06-28
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE
Active strength
300 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