TRAMADOL HYDROCHLORIDE

Product NDC
35356-547
11-digit product format
353560547
Labeler code
35356
Product ID
35356-547_dfd77da2-6f3c-44f3-b70d-94189aa729ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tramadol hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA078783
Marketing category
ANDA
Marketing start
2011-06-01
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE
Active strength
200 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