TRAMADOL HYDROCHLORIDE

Product NDC
71335-1003
11-digit product format
713351003
Labeler code
71335
Product ID
71335-1003_955135d5-2879-413e-ae5c-a38b44bf001a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TRAMADOL HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1003-1EA - Each71335-1003c74e187e-d918-4b09-a730-b51889c4ed6112019-06-19
71335-1003-3EA - Each71335-1003821ecfd3-1abc-4454-b133-7591f19e55dc12019-06-19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1003-1713351003018 TABLET, FILM COATED in 1 BOTTLE (71335-1003-1) 2019-02-210000-00-00NoNoCurrent
71335-1003-27133510030284 TABLET, FILM COATED in 1 BOTTLE (71335-1003-2) 2021-12-280000-00-00NoNoCurrent
71335-1003-37133510030356 TABLET, FILM COATED in 1 BOTTLE (71335-1003-3) 2018-11-140000-00-00NoNoCurrent
71335-1003-47133510030410 TABLET, FILM COATED in 1 BOTTLE (71335-1003-4) 2021-12-280000-00-00NoNoCurrent