Tramadol Hydrochloride

Product NDC
51079-991
11-digit product format
510790991
Labeler code
51079
Product ID
51079-991_d3d75834-1d2a-3bbb-e053-2995a90aa0ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tramadol hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA075986
Marketing category
ANDA
Marketing start
2002-08-01
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
2022-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-991-2051079099120100 BLISTER PACK in 1 CARTON (51079-991-20) > 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-991-01) 100 blister pack2002-08-010000-00-00NoNoCurrent