TRAMADOL HYDROCHLORIDE

Product NDC
65841-754
11-digit product format
658410754
Labeler code
65841
Product ID
65841-754_e3262a8a-7191-474e-a8e2-322a3d3af651
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA090404
Marketing category
ANDA
Marketing start
2011-01-31
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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-754-0165841075401100 TABLET, FILM COATED in 1 BOTTLE (65841-754-01) 2011-01-310000-00-00NoNoCurrent
65841-754-0565841075405500 TABLET, FILM COATED in 1 BOTTLE (65841-754-05) 2011-01-310000-00-00NoNoCurrent
65841-754-10658410754101000 TABLET, FILM COATED in 1 BOTTLE (65841-754-10) 2011-01-310000-00-00NoNoCurrent
65841-754-306584107543010 BLISTER PACK in 1 CARTON (65841-754-30) > 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2011-01-310000-00-00NoNoCurrent