Tramadol Hydrochloride

Product NDC
0615-8005
11-digit product format
006158005
Labeler code
0615
Product ID
0615-8005_66e5e891-13bd-48eb-972a-641c6482c8b7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
TABLET, COATED
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA076003
Marketing category
ANDA
Marketing start
2010-11-15
Marketing end
2024-02-28
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
0000-00-00
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0615-8005-390061580053930 TABLET, COATED in 1 BLISTER PACK (0615-8005-39) 2016-05-092024-02-28NoNoCurrent